Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
// Product Stability Study
{
"resourceType" : "Bundle",
"id" : "bundle-drug-stability-pq-ex1-prod",
"meta" : // <id value="product-stability-study"/>
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"
]
},
"type" : "collection",
"entry" : [
// Section 11 - Stability Study - Results
{
"fullUrl" : "urn:uuid:6f4a3311-92c5-2b4a-533e-76341e414c63",
"resource" : {
"resourceType" : "DiagnosticReport",
"id" : "diagnosticreport-analysis-drug-pq-stability-prod",
"meta" : // <id value="studyResultsReport"/>
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DiagnosticReport</b><a name=\"diagnosticreport-analysis-drug-pq-stability-prod\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DiagnosticReport "diagnosticreport-analysis-drug-pq-stability-prod" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-DiagnosticReport-analysis-drug-pq.html\">DiagnosticReport - Analysis Drug PQ</a></p></div><p><b>Triggered by</b>: <a href=\"#PlanDefinition_c96cb248-1408-79fc-1f47-b17a6b2e4b54\">See above (PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54)</a></p><p><b>Extension - Statistical Model PQ</b>: information about statistical model utilized to interpret stability study results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>Extension - Container Orientation PQ</b>: Horizontal <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-containerOrientation-local-pq.html\">CodeSystem - Container Orientation</a>#horizontal "horizontal")</span></p><p><b>identifier</b>: id:\u00a0ABC1234</p><p><b>status</b>: final</p><p><b>code</b>: Stability Study Report - 18 months <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-reportType-local-pq.html\">CodeSystem - Report Type</a>#Stability Study Report - 18 months)</span></p><p><b>effective</b>: 2020-12</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>result</b>: </p><ul><li><a href=\"#Observation_6fabbf78-9678-8030-485f-b149956308d5\">See above (Observation/6fabbf78-9678-8030-485f-b149956308d5)</a></li><li><a href=\"#Observation_74535cc6-5232-5ab5-81cf-167a480795e5\">See above (Observation/74535cc6-5232-5ab5-81cf-167a480795e5)</a></li><li><a href=\"#Observation_8bf75da1-9221-66fe-6725-c64cb45a57e6\">See above (Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6)</a></li><li><a href=\"#Observation_e803ad6d-0cb3-87dd-6af1-4b88c654a47c\">See above (Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c)</a></li><li><a href=\"#Observation_3519f84a-2889-90a0-a6b7-ff2f1be66a73\">See above (Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73)</a></li><li><a href=\"#Observation_2ef362f1-0b65-3578-7f06-fbd74a24694a\">See above (Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a)</a></li><li><a href=\"#Observation_72e0640b-094b-909e-5268-3dee92af4bbd\">See above (Observation/72e0640b-094b-909e-5268-3dee92af4bbd)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is that the shelf life can be 18 months.</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54"
}
},
// PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq",
"valueCodeableConcept" : {
"text" : "information about statistical model utilized to interpret stability study results"
}
},
// Want to use studyDesign, but problem is that this is CodeableConcept, which allows text. However when you use text, you then
have no place to put a context. Ideally this would be a code/code pair.
Code says "statistical model", code (or text) then says what it is
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-containerOrientation-local-pq",
"code" : "horizontal",
"display" : "horizontal"
}
],
"text" : "Horizontal"
}
}
],
"identifier" : [
// Considered ObservatioDefinition.usageContext
{
"system" : "https://eudract.europa.eu/example/identifier",
"value" : "ABC1234"
}
],
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq",
"code" : "Stability Study Report - 18 months",
"display" : "Stability Study Report - 18 months"
}
]
},
"effectiveDateTime" : "2020-12",
"_effectiveDateTime" : {
"extension" : [
// start of stability test
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-timePointDescription-local-pq",
"code" : "Delayed Start Code",
"display" : "Delayed Start Code"
}
],
"text" : "Refrigerated delayed testing"
}
}
]
},
"performer" : [
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"result" : [
// Organization/tester
{
"reference" : "Observation/6fabbf78-9678-8030-485f-b149956308d5"
},
// Observation/observation-test-result-longterm25c-initial-1
{
"reference" : "Observation/74535cc6-5232-5ab5-81cf-167a480795e5"
},
// Observation/LongTerm25C-initial-2
{
"reference" : "Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6"
},
// Observation/LongTerm25C-initial-3
{
"reference" : "Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c"
},
// Observation/LongTerm25C-18m-1
{
"reference" : "Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73"
},
// Observation/LongTerm25C-18m-2
{
"reference" : "Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a"
},
// Observation/LongTerm25C-18m-3
{
"reference" : "Observation/72e0640b-094b-909e-5268-3dee92af4bbd"
}
],
"conclusion" : "The samples have been assessed and the conclusion is that the shelf life can be 18 months."
}
},
// Observation/Accelerated40C-3-1
// skipping middle months
// Accelerated
// skipping rest of Accelerated
{
"fullUrl" : "urn:uuid:c96cb248-1408-79fc-1f47-b17a6b2e4b54",
"resource" : // Section 11 - Stability Study - Protocol
// end of accelerated
{
"resourceType" : "PlanDefinition",
"id" : "c96cb248-1408-79fc-1f47-b17a6b2e4b54",
"meta" : // <id value="stabilityStudyProtocol"/>
// id value="plandefinition-stability-study-protocol-dxpq-ex1"/
// plandefinition-drug-pq-ex5-stability-study-protocol
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"c96cb248-1408-79fc-1f47-b17a6b2e4b54\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "c96cb248-1408-79fc-1f47-b17a6b2e4b54" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54</code></p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (planType#1244588)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>description</b>: Narrative description of Stability Study</p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 25°C/60% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Accelerated</p><p><b>description</b>: 40°C/75% RH</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54",
"title" : "Stability Monitoring Program",
"type" : // http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54
// Added type (8/22/2023)
{
"coding" : [
{
"system" : "http://example.org/fhir/code/planType",
"code" : "1244588",
"display" : "Stability Study Protocol"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"description" : "Narrative description of Stability Study",
"action" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"title" : "Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg",
"action" : [
// this is then entire thing
{
"title" : "Long-Term",
"description" : "25°C/60% RH",
"action" : [
// TODO add codes here for the different levels?
{
"title" : "Initial",
"timingTiming" : // 0 months
{
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XYZ",
"definitionCanonical" : "ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"
}
]
},
// the categories to do at this step
// Long term
// ActivityDefinition/activitydefinition-test-drug-pq-ex1
{
"title" : "3",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2"
}
]
},
// ActivityDefinition/activitydefinition-stability-test-dxpq-ex1
{
"title" : "6",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732"
}
]
},
// ActivityDefinition/activityLongTerm25X-6
{
"title" : "9",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0"
}
]
},
// ActivityDefinition/activityLongTerm25X-9
{
"title" : "12",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XY",
"definitionCanonical" : "ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b"
}
]
},
// ActivityDefinition/activityLongTerm25XY-12
{
"title" : "18",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XY",
"definitionCanonical" : "ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"
}
]
},
// ActivityDefinition/activityLongTerm25XY-18
{
"title" : "24",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XY",
"definitionCanonical" : "ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2"
}
]
}
]
},
// ActivityDefinition/activityLongTerm25XY-24
// 3 months
// todo put comments back in?
// 6 months
// 9 months
// 12 months
// 18 months
// 24 months
{
"title" : "Accelerated",
"description" : "40°C/75% RH",
"action" : [
{
"title" : "Initial",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XYZ",
"definitionCanonical" : "ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b"
}
]
},
// ActivityDefinition/activityAccelerated40XYZ-Initial
{
"title" : "3",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 3,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50"
}
]
},
// ActivityDefinition/activityAccelerated40X-3
{
"title" : "6",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 6,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "X",
"definitionCanonical" : "ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d"
}
]
},
// ActivityDefinition/activityAccelerated40X-6
{
"title" : "9",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 9,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
{
"title" : "12",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 12,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
{
"title" : "18",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 18,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
},
{
"title" : "24",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 24,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "-"
}
]
}
]
}
]
}
]
}
},
// end of long term
// 0 months is first one - but results for this are not needed, because and zero months is the same for both long term and accelerated
{
"fullUrl" : "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"meta" : // <id value="specimenDefStoredAt25"/>
// specimendefinition-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SpecimenDefinition-drug-pq.html\">SpecimenDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Instruction</b></td></tr><tr><td style=\"display: none\">*</td><td>25°C/60% RH</td></tr></table></blockquote></div>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"status" : "active",
"typeTested" : [
// http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
{
"preference" : "preferred",
"handling" : [
{
"instruction" : "25°C/60% RH"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:610ca25c-6126-6117-8d4d-9458ccc33ce2",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "610ca25c-6126-6117-8d4d-9458ccc33ce2",
"meta" : // <id value="activityLongTerm25X-3"/>
// activitydefinition-stability-test-dxpq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"610ca25c-6126-6117-8d4d-9458ccc33ce2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "610ca25c-6126-6117-8d4d-9458ccc33ce2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2",
"title" : "Long-term - 25°C/60% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2
// changed here to not have url in front
// ObservationDefinition/longTerm25X
{
"fullUrl" : "urn:uuid:d99c1b63-2d32-4887-8157-525cc8ae4732",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "d99c1b63-2d32-4887-8157-525cc8ae4732",
"meta" : // activityLongTerm25X-6
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"d99c1b63-2d32-4887-8157-525cc8ae4732\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "d99c1b63-2d32-4887-8157-525cc8ae4732" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732",
"title" : "Long-term - 25°C/60% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732
// ObservationDefinition/longTerm25X
{
"fullUrl" : "urn:uuid:38704856-0acf-95f0-000f-a933b6862fa0",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "38704856-0acf-95f0-000f-a933b6862fa0",
"meta" : // activityLongTerm25X-9
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"38704856-0acf-95f0-000f-a933b6862fa0\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "38704856-0acf-95f0-000f-a933b6862fa0" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0</code></p><p><b>title</b>: Long-term - 25°C/60% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0",
"title" : "Long-term - 25°C/60% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0
// ObservationDefinition/longTerm25X
{
"fullUrl" : "urn:uuid:4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90",
"meta" : // id value="activityLongTerm25XYZ-Initial"/
// activitydefinition-test-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XYZ</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851\">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409\">http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90",
"title" : "Long-term - 25°C/60% RH - XYZ",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851",
"http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
// ObservationDefinition/longTerm25X
// ObservationDefinition/longTerm25Y
// ObservationDefinition/longTerm25Z
{
"fullUrl" : "urn:uuid:f19a68b0-4ba1-7288-635e-12783035935b",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "f19a68b0-4ba1-7288-635e-12783035935b",
"meta" : // activityLongTerm25XY-12
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"f19a68b0-4ba1-7288-635e-12783035935b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "f19a68b0-4ba1-7288-635e-12783035935b" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851\">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b",
"title" : "Long-term - 25°C/60% RH - XY",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b
// ObservationDefinition/longTerm25X
// ObservationDefinition/longTerm25Y
{
"fullUrl" : "urn:uuid:ce2df6ab-5087-435c-35cb-a84572e756a2",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "ce2df6ab-5087-435c-35cb-a84572e756a2",
"meta" : // activityLongTerm25XY-18
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"ce2df6ab-5087-435c-35cb-a84572e756a2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "ce2df6ab-5087-435c-35cb-a84572e756a2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851\">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2",
"title" : "Long-term - 25°C/60% RH - XY",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2
// ObservationDefinition/longTerm25X
// ObservationDefinition/longTerm25Y
{
"fullUrl" : "urn:uuid:cf2df6ab-5087-435c-35cb-a84572e756a2",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "cf2df6ab-5087-435c-35cb-a84572e756a2",
"meta" : // activityLongTerm25XY-24
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"cf2df6ab-5087-435c-35cb-a84572e756a2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "cf2df6ab-5087-435c-35cb-a84572e756a2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2</code></p><p><b>title</b>: Long-term - 25°C/60% RH - XY</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774\">http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851\">http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2",
"title" : "Long-term - 25°C/60% RH - XY",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2
// ObservationDefinition/longTerm25X
// ObservationDefinition/longTerm25Y
{
"fullUrl" : "urn:uuid:d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"meta" : // longTerm25X
// id value="observationdefinition-test-method-drug-pq-ex1"/
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d1d252cf-9d58-43a0-85f6-56a7f7f92774\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "d1d252cf-9d58-43a0-85f6-56a7f7f92774" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 25°C/60% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></li><li><a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></li><li><a href=\"#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></li></ul></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774",
"title" : "X",
"status" : "active",
"code" : // http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/observationdefinition-test-method-drug-pq-ex1
{
"text" : "Battery of tests 'X' at 25°C/60% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
}
],
"hasMember" : [
// SpecimenDefinition/specimendefinition-drug-pq-ex1
{
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
// ObservationDefinition/Description
{
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
// ObservationDefinition/Degradation
{
"reference" : "ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"
}
]
}
},
// ObservationDefinition/Water
{
"fullUrl" : "urn:uuid:1178fc31-0cfd-8c60-0b5b-9ae2850c6774",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "1178fc31-0cfd-8c60-0b5b-9ae2850c6774",
"meta" : // Description
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"1178fc31-0cfd-8c60-0b5b-9ae2850c6774\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "1178fc31-0cfd-8c60-0b5b-9ae2850c6774" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "An orange film-coated tablet, debossed with 175 on one side"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:2c5683d6-6e94-825b-056a-129a04c95e2f",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "2c5683d6-6e94-825b-056a-129a04c95e2f",
"meta" : // Degradation
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"2c5683d6-6e94-825b-056a-129a04c95e2f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "2c5683d6-6e94-825b-056a-129a04c95e2f" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</code></p><p><b>title</b>: Degradation Products by HPLC (% w/w)</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f",
"title" : "Degradation Products by HPLC (% w/w)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
]
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Any Unspecified Degradation Impurity"
}
],
"range" : {
"high" : {
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"appliesTo" : [
{
"text" : "Total Degradation Impurities"
}
],
"range" : {
"high" : {
"value" : 2.3,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:186eb33e-a01d-4252-166c-b5ba5e8a697c",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "186eb33e-a01d-4252-166c-b5ba5e8a697c",
"meta" : // Water
// id value="observationdefinition-test-method-drug-pq-ex2"/
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"186eb33e-a01d-4252-166c-b5ba5e8a697c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "186eb33e-a01d-4252-166c-b5ba5e8a697c" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</code></p><p><b>title</b>: Water Content (% w/w) (Mean)</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-0.2</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c",
"title" : "Water Content (% w/w) (Mean)",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:b62b9524-53af-84ae-1071-2867a2169851",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "b62b9524-53af-84ae-1071-2867a2169851",
"meta" : // longTerm25Y
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"b62b9524-53af-84ae-1071-2867a2169851\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "b62b9524-53af-84ae-1071-2867a2169851" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 25°C/60% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851",
"title" : "Y",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
{
"text" : "Battery of tests 'Y' at 25°C/60% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
}
],
"hasMember" : [
// SpecimenDefinition/specimendefinition-drug-pq-ex1
{
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
}
]
}
},
// ObservationDefinition/Microbiological
{
"fullUrl" : "urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "73d9d304-a0b8-31b6-1165-346563b9305e",
"meta" : // Microbiological
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"73d9d304-a0b8-31b6-1165-346563b9305e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e",
"title" : "Microbiological",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
],
"text" : "Microbiological Quality"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Complies with PhEur"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:363384c8-0d79-5ff0-5538-4933f99d6409",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "363384c8-0d79-5ff0-5538-4933f99d6409",
"meta" : // longTerm25Z
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"363384c8-0d79-5ff0-5538-4933f99d6409\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "363384c8-0d79-5ff0-5538-4933f99d6409" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409</code></p><p><b>title</b>: Z</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Z' at 25°C/60% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409",
"title" : "Z",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409
{
"text" : "Battery of tests 'Z' at 25°C/60% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
}
],
"hasMember" : [
// SpecimenDefinition/specimendefinition-drug-pq-ex1
{
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
}
]
}
},
// ObservationDefinition/Uniformity
{
"fullUrl" : "urn:uuid:ef781c18-8e86-7859-209b-469ee9ad42d8",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "ef781c18-8e86-7859-209b-469ee9ad42d8",
"meta" : // Uniformity
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"ef781c18-8e86-7859-209b-469ee9ad42d8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "ef781c18-8e86-7859-209b-469ee9ad42d8" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8",
"title" : "Uniformity of dosage",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "uniformity of dosage units (by weight)"
}
],
"text" : "uniformity of dosage units (by weight)"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Complies"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:e95109ac-5ef9-1723-3506-2ef2f2e33d87",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "e95109ac-5ef9-1723-3506-2ef2f2e33d87",
"text" : // specimenDefStoredAt40
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"e95109ac-5ef9-1723-3506-2ef2f2e33d87\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SpecimenDefinition "e95109ac-5ef9-1723-3506-2ef2f2e33d87" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87</code></p><p><b>status</b>: active</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><h3>Handlings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Instruction</b></td></tr><tr><td style=\"display: none\">*</td><td>40°C/75% RH</td></tr></table></blockquote></div>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87",
"status" : "active",
"typeTested" : [
// http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87
{
"preference" : "preferred",
"handling" : [
{
"instruction" : "40°C/75% RH"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:096e3f32-798e-6792-76ad-4ea783521c50",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "096e3f32-798e-6792-76ad-4ea783521c50",
"meta" : // activityAccelerated40X-3
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"096e3f32-798e-6792-76ad-4ea783521c50\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "096e3f32-798e-6792-76ad-4ea783521c50" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b\">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50",
"title" : "Accelerated - 40°C/70% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50
// ObservationDefinition/accelerated40X
{
"fullUrl" : "urn:uuid:77f86b13-8193-3df7-8362-ab5e79ba541d",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "77f86b13-8193-3df7-8362-ab5e79ba541d",
"meta" : // activityAccelerated40X-6
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"77f86b13-8193-3df7-8362-ab5e79ba541d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "77f86b13-8193-3df7-8362-ab5e79ba541d" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - X</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b\">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d",
"title" : "Accelerated - 40°C/70% RH - X",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d
// ObservationDefinition/accelerated40X
{
"fullUrl" : "urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b",
"resource" : {
"resourceType" : "ActivityDefinition",
"id" : "6b96124b-1a44-0b6b-6783-d6c49360230b",
"meta" : // activityAccelerated40XYZ-Initial
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ActivityDefinition</b><a name=\"6b96124b-1a44-0b6b-6783-d6c49360230b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ActivityDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ActivityDefinition-test-drug-pq.html\">ActivityDefinition - Test Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b</code></p><p><b>title</b>: Accelerated - 40°C/70% RH - XYZ</p><p><b>status</b>: active</p><p><b>observationRequirement</b>: <a href=\"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b\">http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2\">http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2</a>, <a href=\"http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0\">http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0</a></p></div>"
},
"url" : "http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b",
"title" : "Accelerated - 40°C/70% RH - XYZ",
"status" : "active",
"observationRequirement" : [
"http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b",
"http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2",
"http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0"
]
}
},
// http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
// ObservationDefinition/accelerated40X
// ObservationDefinition/accelerated40Y
// ObservationDefinition/accelerated40Z
{
"fullUrl" : "urn:uuid:792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b",
"meta" : // accelerated40X
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b</code></p><p><b>title</b>: X</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'X' at 40°C/75% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87\">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></li><li><a href=\"#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></li></ul></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b",
"title" : "X",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
{
"text" : "Battery of tests 'X' at 40°C/75% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt40
{
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
// ObservationDefinition/Description
{
"reference" : "ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"
}
]
}
},
// ObservationDefinition/Water
{
"fullUrl" : "urn:uuid:58cb0710-0ee6-1b7a-2a64-61a01df95ac2",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "58cb0710-0ee6-1b7a-2a64-61a01df95ac2",
"meta" : // accelerated40Y
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"58cb0710-0ee6-1b7a-2a64-61a01df95ac2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "58cb0710-0ee6-1b7a-2a64-61a01df95ac2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2</code></p><p><b>title</b>: Y</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Y' at 40°C/75% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87\">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2",
"title" : "Y",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2
{
"text" : "Battery of tests 'Y' at 40°C/75% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt40
{
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
}
]
}
},
// ObservationDefinition/Microbiological
{
"fullUrl" : "urn:uuid:9bc183ee-6017-789b-8a6f-6a5c339f9ae0",
"resource" : // can have others
{
"resourceType" : "ObservationDefinition",
"id" : "9bc183ee-6017-789b-8a6f-6a5c339f9ae0",
"meta" : // accelerated40Z
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"9bc183ee-6017-789b-8a6f-6a5c339f9ae0\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "9bc183ee-6017-789b-8a6f-6a5c339f9ae0" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0</code></p><p><b>title</b>: Z</p><p><b>status</b>: active</p><p><b>code</b>: Battery of tests 'Z' at 25°C/60% RH <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_e95109ac-5ef9-1723-3506-2ef2f2e33d87\">See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)</a></p><p><b>hasMember</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0",
"title" : "Z",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0
{
"text" : "Battery of tests 'Z' at 25°C/60% RH"
},
"specimen" : [
{
"reference" : "SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87"
}
],
"hasMember" : [
// SpecimenDefinition/specimenDefStoredAt40
{
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
}
]
}
},
// ObservationDefinition/Uniformity
{
"fullUrl" : "urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd",
"resource" : {
"resourceType" : "Specimen",
"id" : "b664977d-799d-a1ce-928a-5def2a9955bd",
"meta" : // id value="stabilityInitial-1"/
// specimen-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"b664977d-799d-a1ce-928a-5def2a9955bd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955bd" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Specimen-drug-pq.html\">Specimen - Drug PQ</a></p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-01</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-01"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:b664977d-799d-a1ce-928a-5def2a9955be",
"resource" : {
"resourceType" : "Specimen",
"id" : "b664977d-799d-a1ce-928a-5def2a9955be",
"meta" : // stabilityInitial-2
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"b664977d-799d-a1ce-928a-5def2a9955be\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955be" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Specimen-drug-pq.html\">Specimen - Drug PQ</a></p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-02</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-02"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:b664977d-799d-a1ce-928b-5def2a9955be",
"resource" : {
"resourceType" : "Specimen",
"id" : "b664977d-799d-a1ce-928b-5def2a9955be",
"meta" : // stabilityInitial-3
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"b664977d-799d-a1ce-928b-5def2a9955be\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "b664977d-799d-a1ce-928b-5def2a9955be" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Specimen-drug-pq.html\">Specimen - Drug PQ</a></p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-03</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: No storage</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-03"
},
"processing" : [
{
"description" : "No storage"
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:6fabbf78-9678-8030-485f-b149956308d5",
"resource" : {
"resourceType" : "Observation",
"id" : "6fabbf78-9678-8030-485f-b149956308d5",
"meta" : // id value="LongTerm25C-initial-1"/
// observation-test-result-longterm25c-initial-1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"6fabbf78-9678-8030-485f-b149956308d5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "6fabbf78-9678-8030-485f-b149956308d5" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Observation-test-result-drug-pq.html\">Observation - Test Result Drug PQ</a></p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90\">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_b664977d-799d-a1ce-928a-5def2a9955bd\">See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955bd)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-initial-1-Description\"> </a></li><li><a name=\"observation-test-result-lt25c-i1-degradation-imp1\"> </a></li><li><a name=\"LongTerm25C-initial-1-Degradation-imp2\"> </a></li><li><a name=\"LongTerm25C-initial-1-Degradation-imp3\"> </a></li><li><a name=\"LongTerm25C-initial-1-Degradation-impUnspecified\"> </a></li><li><a name=\"LongTerm25C-initial-1-Degradation-impTotal\"> </a></li><li><a name=\"LongTerm25C-initial-1-Water\"> </a></li><li><a name=\"LongTerm25C-initial-1-Microbiological\"> </a></li><li><a name=\"LongTerm25C-initial-1-Uniformity\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"observation-test-result-lt25c-i1-degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.801 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1501 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Description</b><a name=\"LongTerm25C-initial-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #observation-test-result-lt25c-i1-degradation-imp1</b><a name=\"observation-test-result-lt25c-i1-degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp2</b><a name=\"LongTerm25C-initial-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp3</b><a name=\"LongTerm25C-initial-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impUnspecified</b><a name=\"LongTerm25C-initial-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impTotal</b><a name=\"LongTerm25C-initial-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.801 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Water</b><a name=\"LongTerm25C-initial-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1501 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Microbiological</b><a name=\"LongTerm25C-initial-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-1-Uniformity</b><a name=\"LongTerm25C-initial-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Description",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "observation-test-result-lt25c-i1-degradation-imp1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.101,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Degradation-imp2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.201,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Degradation-imp3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.201,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Degradation-impUnspecified",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.101,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Degradation Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Degradation-impTotal",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.801,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Degradation Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Water",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.1501,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Microbiological",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-1-Uniformity",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
},
"status" : "final",
"code" : // ObservationDefinition/Uniformity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "Uniformity of dosage units (by weight)"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
}
],
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activitydefinition-test-drug-pq-ex1
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/b664977d-799d-a1ce-928a-5def2a9955bd"
},
"hasMember" : [
// Specimen/specimen-drug-pq-ex1
{
"reference" : "#LongTerm25C-initial-1-Description"
},
{
"reference" : "#observation-test-result-lt25c-i1-degradation-imp1"
},
{
"reference" : "#LongTerm25C-initial-1-Degradation-imp2"
},
{
"reference" : "#LongTerm25C-initial-1-Degradation-imp3"
},
{
"reference" : "#LongTerm25C-initial-1-Degradation-impUnspecified"
},
{
"reference" : "#LongTerm25C-initial-1-Degradation-impTotal"
},
{
"reference" : "#LongTerm25C-initial-1-Water"
},
{
"reference" : "#LongTerm25C-initial-1-Microbiological"
},
{
"reference" : "#LongTerm25C-initial-1-Uniformity"
}
]
}
},
{
"fullUrl" : "urn:uuid:74535cc6-5232-5ab5-81cf-167a480795e5",
"resource" : {
"resourceType" : "Observation",
"id" : "74535cc6-5232-5ab5-81cf-167a480795e5",
"text" : // LongTerm25C-initial-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"74535cc6-5232-5ab5-81cf-167a480795e5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "74535cc6-5232-5ab5-81cf-167a480795e5" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90\">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_b664977d-799d-a1ce-928a-5def2a9955be\">See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955be)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-initial-2-Description\"> </a></li><li><a name=\"LongTerm25C-initial-2-Degradation\"> </a></li><li><a name=\"LongTerm25C-initial-2-Microbiological\"> </a></li><li><a name=\"LongTerm25C-initial-2-Uniformity\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-initial-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-2-Degradation\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-2-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies</p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-2-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Description</b><a name=\"LongTerm25C-initial-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Degradation</b><a name=\"LongTerm25C-initial-2-Degradation\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Microbiological</b><a name=\"LongTerm25C-initial-2-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-2-Uniformity</b><a name=\"LongTerm25C-initial-2-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-2-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-2-Degradation",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-2-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueString" : "Complies"
},
// Organization/tester
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-2-Uniformity",
"instantiatesReference" : {
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
},
"status" : "final",
"code" : // ObservationDefinition/Uniformity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "Uniformity of dosage units (by weight)"
}
]
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
}
],
"extension" : [
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activitydefinition-test-drug-pq-ex1
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/b664977d-799d-a1ce-928a-5def2a9955be"
},
"hasMember" : [
// Specimen/stabilityInitial-2
{
"reference" : "#LongTerm25C-initial-2-Description"
},
{
"reference" : "#LongTerm25C-initial-2-Degradation"
},
{
"reference" : "#LongTerm25C-initial-2-Microbiological"
},
{
"reference" : "#LongTerm25C-initial-2-Uniformity"
}
]
}
},
{
"fullUrl" : "urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6",
"resource" : {
"resourceType" : "Observation",
"id" : "8bf75da1-9221-66fe-6725-c64cb45a57e6",
"text" : // LongTerm25C-initial-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"8bf75da1-9221-66fe-6725-c64cb45a57e6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90\">See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_b664977d-799d-a1ce-928b-5def2a9955be\">See above (Specimen/b664977d-799d-a1ce-928b-5def2a9955be)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-initial-3-Description\"> </a></li><li><a name=\"LongTerm25C-initial-3-Degradation\"> </a></li><li><a name=\"LongTerm25C-initial-3-Microbiological\"> </a></li><li><a name=\"LongTerm25C-initial-3-Uniformity\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-initial-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-3-Degradation\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-3-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-initial-3-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Description</b><a name=\"LongTerm25C-initial-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Degradation</b><a name=\"LongTerm25C-initial-3-Degradation\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Microbiological</b><a name=\"LongTerm25C-initial-3-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-initial-3-Uniformity</b><a name=\"LongTerm25C-initial-3-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-3-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-3-Degradation",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-3-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-initial-3-Uniformity",
"instantiatesReference" : {
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
},
"status" : "final",
"code" : // ObservationDefinition/Uniformity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "Uniformity of dosage units (by weight)"
}
]
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
}
],
"extension" : [
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activitydefinition-test-drug-pq-ex1
{
"text" : "Test Components - Long-term 25C etc - Initial (XYZ)"
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/b664977d-799d-a1ce-928b-5def2a9955be"
},
"hasMember" : [
// Specimen/stabilityInitial-3
{
"reference" : "#LongTerm25C-initial-3-Description"
},
{
"reference" : "#LongTerm25C-initial-3-Degradation"
},
{
"reference" : "#LongTerm25C-initial-3-Microbiological"
},
{
"reference" : "#LongTerm25C-initial-3-Uniformity"
}
]
}
},
{
"fullUrl" : "urn:uuid:18826818-10c4-972c-618e-01694ff06c78",
"resource" : {
"resourceType" : "Specimen",
"id" : "18826818-10c4-972c-618e-01694ff06c78",
"text" : // stability18months-1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"18826818-10c4-972c-618e-01694ff06c78\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "18826818-10c4-972c-618e-01694ff06c78" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-01</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-01"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : // 18 months
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:18826818-10c4-972c-618e-01694ff06c88",
"resource" : {
"resourceType" : "Specimen",
"id" : "18826818-10c4-972c-618e-01694ff06c88",
"text" : // stability18months-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"18826818-10c4-972c-618e-01694ff06c88\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "18826818-10c4-972c-618e-01694ff06c88" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-02</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-02"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : // 18 months
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:18826818-10c4-972c-618e-01694ff06c89",
"resource" : {
"resourceType" : "Specimen",
"id" : "18826818-10c4-972c-618e-01694ff06c89",
"text" : // stability18months-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"18826818-10c4-972c-618e-01694ff06c89\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "18826818-10c4-972c-618e-01694ff06c89" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-03</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 18 months</p><p><b>time</b>: 2020-12 --> 2022-06</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 25°C/60% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-03"
},
"processing" : [
{
"description" : "Store for 18 months",
"timePeriod" : // 18 months
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2022-06"
}
},
{
"description" : "25°C/60% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:e803ad6d-0cb3-87dd-6af1-4b88c654a47c",
"resource" : {
"resourceType" : "Observation",
"id" : "e803ad6d-0cb3-87dd-6af1-4b88c654a47c",
"text" : // LongTerm25C-18m-1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"e803ad6d-0cb3-87dd-6af1-4b88c654a47c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "e803ad6d-0cb3-87dd-6af1-4b88c654a47c" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2\">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_18826818-10c4-972c-618e-01694ff06c78\">See above (Specimen/18826818-10c4-972c-618e-01694ff06c78)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-18m-1-Description\"> </a></li><li><a name=\"LongTerm25C-18m-1-Degradation-imp1\"> </a></li><li><a name=\"LongTerm25C-18m-1-Degradation-imp2\"> </a></li><li><a name=\"LongTerm25C-18m-1-Degradation-imp3\"> </a></li><li><a name=\"LongTerm25C-18m-1-Degradation-impUnspecified\"> </a></li><li><a name=\"LongTerm25C-18m-1-Degradation-impTotal\"> </a></li><li><a name=\"LongTerm25C-18m-1-Water\"> </a></li><li><a name=\"LongTerm25C-18m-1-Microbiological\"> </a></li><li><a name=\"LongTerm25C-18m-1-Uniformity\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies</p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Description</b><a name=\"LongTerm25C-18m-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp1</b><a name=\"LongTerm25C-18m-1-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp2</b><a name=\"LongTerm25C-18m-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp3</b><a name=\"LongTerm25C-18m-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.218 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impUnspecified</b><a name=\"LongTerm25C-18m-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.118 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impTotal</b><a name=\"LongTerm25C-18m-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.818 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Water</b><a name=\"LongTerm25C-18m-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1518 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Microbiological</b><a name=\"LongTerm25C-18m-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-1-Uniformity</b><a name=\"LongTerm25C-18m-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Degradation-imp1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
]
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.118,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Degradation-imp2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.218,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Degradation-imp3",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.218,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Degradation-impUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.118,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Degradation Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Degradation-impTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.818,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Degradation Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Water",
"instantiatesReference" : {
"reference" : "ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.1518,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueString" : "Complies"
},
// Organization/tester
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-1-Uniformity",
"instantiatesReference" : {
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
},
"status" : "final",
"code" : // ObservationDefinition/Uniformity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "Uniformity of dosage units (by weight)"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
}
],
"extension" : [
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm25XY-18
{
"text" : "Test Components - Long-term 25C etc - 18 months (XY)"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/18826818-10c4-972c-618e-01694ff06c78"
},
"hasMember" : [
// Specimen/stability18months-1
{
"reference" : "#LongTerm25C-18m-1-Description"
},
{
"reference" : "#LongTerm25C-18m-1-Degradation-imp1"
},
{
"reference" : "#LongTerm25C-18m-1-Degradation-imp2"
},
{
"reference" : "#LongTerm25C-18m-1-Degradation-imp3"
},
{
"reference" : "#LongTerm25C-18m-1-Degradation-impUnspecified"
},
{
"reference" : "#LongTerm25C-18m-1-Degradation-impTotal"
},
{
"reference" : "#LongTerm25C-18m-1-Water"
},
{
"reference" : "#LongTerm25C-18m-1-Microbiological"
},
{
"reference" : "#LongTerm25C-18m-1-Uniformity"
}
]
}
},
{
"fullUrl" : "urn:uuid:3519f84a-2889-90a0-a6b7-ff2f1be66a73",
"resource" : {
"resourceType" : "Observation",
"id" : "3519f84a-2889-90a0-a6b7-ff2f1be66a73",
"text" : // LongTerm25C-18m-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"3519f84a-2889-90a0-a6b7-ff2f1be66a73\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "3519f84a-2889-90a0-a6b7-ff2f1be66a73" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2\">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_18826818-10c4-972c-618e-01694ff06c88\">See above (Specimen/18826818-10c4-972c-618e-01694ff06c88)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-18m-2-Description\"> </a></li><li><a name=\"LongTerm25C-18m-2-Microbiological\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-18m-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-2-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Does not comply</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-2-Description</b><a name=\"LongTerm25C-18m-2-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-2-Microbiological</b><a name=\"LongTerm25C-18m-2-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_8306cfc5-158f-1a53-a683-048b226060d9\">Medication/8306cfc5-158f-1a53-a683-048b226060d9</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Does not comply</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-2-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-2-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueString" : "Does not comply"
}
],
"extension" : [
// Organization/tester
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm25XY-18
{
"text" : "Test Components - Long-term 25C etc - 18 months (XY)"
},
"subject" : {
"reference" : "Medication/8306cfc5-158f-1a53-a683-048b226060d9"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-2
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/18826818-10c4-972c-618e-01694ff06c88"
},
"hasMember" : [
// Specimen/stability18months-2
{
"reference" : "#LongTerm25C-18m-2-Description"
},
{
"reference" : "#LongTerm25C-18m-2-Microbiological"
}
]
}
},
{
"fullUrl" : "urn:uuid:2ef362f1-0b65-3578-7f06-fbd74a24694a",
"resource" : {
"resourceType" : "Observation",
"id" : "2ef362f1-0b65-3578-7f06-fbd74a24694a",
"text" : // LongTerm25C-18m-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"2ef362f1-0b65-3578-7f06-fbd74a24694a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "2ef362f1-0b65-3578-7f06-fbd74a24694a" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_ce2df6ab-5087-435c-35cb-a84572e756a2\">See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - 18 months (XY) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_18826818-10c4-972c-618e-01694ff06c89\">See above (Specimen/18826818-10c4-972c-618e-01694ff06c89)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"LongTerm25C-18m-3-Description\"> </a></li><li><a name=\"LongTerm25C-18m-3-Microbiological\"> </a></li></ul><blockquote><p/><p><a name=\"LongTerm25C-18m-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"LongTerm25C-18m-3-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Does not comply</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-3-Description</b><a name=\"LongTerm25C-18m-3-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #LongTerm25C-18m-3-Microbiological</b><a name=\"LongTerm25C-18m-3-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\">Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Does not comply</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-3-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "LongTerm25C-18m-3-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueString" : "Does not comply"
}
],
"extension" : [
// Organization/tester
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityLongTerm25XY-18
{
"text" : "Test Components - Long-term 25C etc - 18 months (XY)"
},
"subject" : {
"reference" : "Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch-3
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/18826818-10c4-972c-618e-01694ff06c89"
},
"hasMember" : [
// Specimen/stability18months-3
{
"reference" : "#LongTerm25C-18m-3-Description"
},
{
"reference" : "#LongTerm25C-18m-3-Microbiological"
}
]
}
},
{
"fullUrl" : "urn:uuid:8a7771db-5cc0-33f8-966a-b2f792bf5785",
"resource" : {
"resourceType" : "Specimen",
"id" : "8a7771db-5cc0-33f8-966a-b2f792bf5785",
"text" : // stabilityInitialAcc-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Specimen</b><a name=\"8a7771db-5cc0-33f8-966a-b2f792bf5785\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Specimen "8a7771db-5cc0-33f8-966a-b2f792bf5785" </p></div><h3>Collections</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Collected[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>2020-12-01</td></tr></table><blockquote><p><b>processing</b></p><p><b>description</b>: Store for 3 months</p><p><b>time</b>: 2020-12 --> 2021-03</p></blockquote><blockquote><p><b>processing</b></p><p><b>description</b>: 40°C/75% RH</p></blockquote></div>"
},
"collection" : // when sample first taken, before the timed periods start
{
"collectedDateTime" : "2020-12-01"
},
"processing" : [
{
"description" : "Store for 3 months",
"timePeriod" : // 3 months
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq",
"valueDuration" : {
"value" : 18,
"unit" : "month"
}
}
],
"start" : "2020-12",
"end" : "2021-03"
}
},
{
"description" : "40°C/75% RH"
}
]
}
},
{
"fullUrl" : "urn:uuid:72e0640b-094b-909e-5268-3dee92af4bbd",
"resource" : {
"resourceType" : "Observation",
"id" : "72e0640b-094b-909e-5268-3dee92af4bbd",
"text" : // Accelerated40C-3-1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"72e0640b-094b-909e-5268-3dee92af4bbd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "72e0640b-094b-909e-5268-3dee92af4bbd" </p></div><p><b>Triggered by</b>: <a href=\"#ActivityDefinition_096e3f32-798e-6792-76ad-4ea783521c50\">See above (ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50)</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Accelerated 40C etc - 3 Months (X) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>specimen</b>: <a href=\"#Specimen_8a7771db-5cc0-33f8-966a-b2f792bf5785\">See above (Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785)</a></p><p><b>hasMember</b>: </p><ul><li><a name=\"Accelerated40C-3-1-Description\"> </a></li><li><a name=\"Accelerated40C-3-1-Degradation-imp1\"> </a></li><li><a name=\"Accelerated40C-3-1-Degradation-imp2\"> </a></li><li><a name=\"Accelerated40C-3-1-Degradation-imp3\"> </a></li><li><a name=\"Accelerated40C-3-1-Degradation-impUnspecified\"> </a></li><li><a name=\"Accelerated40C-3-1-Degradation-impTotal\"> </a></li><li><a name=\"Accelerated40C-3-1-Water\"> </a></li><li><a name=\"Accelerated40C-3-1-Microbiological\"> </a></li><li><a name=\"Accelerated40C-3-1-Uniformity\"> </a></li></ul><blockquote><p/><p><a name=\"Accelerated40C-3-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.143 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.243 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: <0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.801 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: 0.1501 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p/><p><a name=\"Accelerated40C-3-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Description</b><a name=\"Accelerated40C-3-1-Description\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_1178fc31-0cfd-8c60-0b5b-9ae2850c6774\">ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp1</b><a name=\"Accelerated40C-3-1-Degradation-imp1\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.143 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp2</b><a name=\"Accelerated40C-3-1-Degradation-imp2\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.243 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp3</b><a name=\"Accelerated40C-3-1-Degradation-imp3\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.201 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impUnspecified</b><a name=\"Accelerated40C-3-1-Degradation-impUnspecified\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: <0.101 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any Unspecified Degradation Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impTotal</b><a name=\"Accelerated40C-3-1-Degradation-impTotal\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_2c5683d6-6e94-825b-056a-129a04c95e2f\">ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f</a></p><p><b>status</b>: final</p><p><b>code</b>: Degradation Products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.801 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total Degradation Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Water</b><a name=\"Accelerated40C-3-1-Water\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_186eb33e-a01d-4252-166c-b5ba5e8a697c\">ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: 0.1501 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Microbiological</b><a name=\"Accelerated40C-3-1-Microbiological\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_73d9d304-a0b8-31b6-1165-346563b9305e\">ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e</a></p><p><b>status</b>: final</p><p><b>code</b>: Microbiological Quality <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><hr/><blockquote><p><b>Generated Narrative: Observation #Accelerated40C-3-1-Uniformity</b><a name=\"Accelerated40C-3-1-Uniformity\"> </a></p><p><b>instantiates</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#ObservationDefinition_ef781c18-8e86-7859-209b-469ee9ad42d8\">ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8</a></p><p><b>status</b>: final</p><p><b>code</b>: Uniformity of dosage units (by weight) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>subject</b>: <a href=\"Bundle-bundle-drug-stability-pq-ex1-prod.html#Medication_7ef62d57-7cc6-9211-66d6-abc7e096093c\">Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Bundle-bundle-product-impurities-pq-ex1.html#Organization_e3d2bc19-2f10-2b4d-1741-e4135fe612a9\">Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9</a></p><p><b>value</b>: Complies <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Description",
"instantiatesReference" : {
"reference" : "ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Degradation-imp1",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.143,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Degradation-imp2",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.243,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
},
// could have the code of an impurity substance, or could have an extension to point to it as a resource
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Degradation-imp3",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.201,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Degradation-impUnspecified",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.101,
"comparator" : "<",
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any Unspecified Degradation Impurity"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Degradation-impTotal",
"instantiatesReference" : {
"reference" : "ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"
},
"status" : "final",
"code" : // ObservationDefinition/Degradation
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
],
"text" : "Degradation Products"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.801,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total Degradation Impurities"
}
}
]
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Water",
"instantiatesReference" : {
"reference" : "ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueQuantity" : // Organization/tester
{
"value" : 0.1501,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Microbiological",
"instantiatesReference" : {
"reference" : "ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"
},
"status" : "final",
"code" : // ObservationDefinition/Microbiological
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
},
{
"resourceType" : "Observation",
"id" : "Accelerated40C-3-1-Uniformity",
"instantiatesReference" : {
"reference" : "ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"
},
"status" : "final",
"code" : // ObservationDefinition/Uniformity
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "uniformity-dosage",
"display" : "Uniformity of dosage units (by weight)"
}
]
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"valueCodeableConcept" : // Organization/tester
{
"text" : "Complies"
}
}
],
"extension" : [
// use a standard extension to say what plan this is being done for. However it doesn't link to the step of that plan
that would mean using sub-ActivityDefintions probably
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50"
}
}
],
"status" : "final",
"code" : // ActivityDefinition/activityAccelerated40X-3
{
"text" : "Test Components - Accelerated 40C etc - 3 Months (X)"
},
"subject" : {
"reference" : "Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-batch-information-drug-pq-ex1
{
"reference" : "Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
}
],
"specimen" : // Organization/tester
{
"reference" : "Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785"
},
"hasMember" : [
// Specimen/stabilityInitialAcc-3
{
"reference" : "#Accelerated40C-3-1-Description"
},
{
"reference" : "#Accelerated40C-3-1-Degradation-imp1"
},
{
"reference" : "#Accelerated40C-3-1-Degradation-imp2"
},
{
"reference" : "#Accelerated40C-3-1-Degradation-imp3"
},
{
"reference" : "#Accelerated40C-3-1-Degradation-impUnspecified"
},
{
"reference" : "#Accelerated40C-3-1-Degradation-impTotal"
},
{
"reference" : "#Accelerated40C-3-1-Water"
},
{
"reference" : "#Accelerated40C-3-1-Microbiological"
},
{
"reference" : "#Accelerated40C-3-1-Uniformity"
}
]
}
},
{
"fullUrl" : "urn:uuid:7ef62d57-7cc6-9211-66d6-abc7e096093c",
"resource" : {
"resourceType" : "Medication",
"id" : "7ef62d57-7cc6-9211-66d6-abc7e096093c",
"meta" : // <id value="medication-actual-batch"/>
// medication-batch-information-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"7ef62d57-7cc6-9211-66d6-abc7e096093c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "7ef62d57-7cc6-9211-66d6-abc7e096093c" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Medication-batch-information-drug-pq.html\">Medication - Batch Information Drug PQ</a></p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , </td><td>33445</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // todo consider change this be the MID?
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100100,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
},
// Organization/organization-drug-pq-ex1
{
"url" : "container",
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"text" : "100 cc HDPE Bottle 2 g desiccant"
}
},
{
"url" : "closureSystemDescription",
"valueString" : "Standard closure"
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/fc078762-81c5-5656-9744-13c7ad1e595b"
}
},
// Substance/substance-dxpq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"lotNumber" : "33445"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9",
"resource" : {
"resourceType" : "Medication",
"id" : "8306cfc5-158f-1a53-a683-048b226060d9",
"text" : // medication-actual-batch-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"8306cfc5-158f-1a53-a683-048b226060d9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "8306cfc5-158f-1a53-a683-048b226060d9" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , </td><td>33446</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100050,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"
}
},
// Organization/manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"text" : "100 cc HDPE Bottle 2 g desiccant"
}
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/cb31d747-2338-88d5-342c-8e9c097e4dad"
}
},
// Substance/actual-batch-substance-2
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"lotNumber" : "33446"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:f54d4666-7ae3-4e30-8c5a-6d13838c4f3b",
"resource" : {
"resourceType" : "Medication",
"id" : "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b",
"text" : // medication-actual-batch-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"f54d4666-7ae3-4e30-8c5a-6d13838c4f3b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , </td><td>33447</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100125,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"
}
},
// Organization/manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "type",
"valueCodeableConcept" : {
"text" : "100 cc HDPE Bottle 2 g desiccant"
}
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : {
"reference" : "Substance/1551f97b-6f6d-825e-1fb3-44b0b090808c"
}
},
// Substance/actual-batch-substance-3
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"lotNumber" : "33447"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd",
"resource" : {
"resourceType" : "Organization",
"id" : "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd",
"text" : // manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"033ce81d-5f0d-7a3e-93d3-fc64e122a1fd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" </p></div><p><b>identifier</b>: id:\u00a03010027650</p><p><b>name</b>: AAA Pharmaceutical, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3010027650"
}
],
"name" : "AAA Pharmaceutical, Inc.",
"contact" : [
// FDA establishment identifier
// contact>
<address></address>
</contact
{
"address" : {
"line" : [
"681 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
// todo change to be contact/address
{
"fullUrl" : "urn:uuid:2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc",
"resource" : {
"resourceType" : "Organization",
"id" : "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc",
"text" : // packaging
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc" </p></div><p><b>name</b>: MySite</p></div>"
},
"name" : "MySite"
}
},
{
"fullUrl" : "urn:uuid:e3d2bc19-2f10-2b4d-1741-e4135fe612a9",
"resource" : {
"resourceType" : "Organization",
"id" : "e3d2bc19-2f10-2b4d-1741-e4135fe612a9",
"text" : // tester
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"e3d2bc19-2f10-2b4d-1741-e4135fe612a9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9" </p></div><p><b>identifier</b>: id:\u00a03007270600</p><p><b>name</b>: Advanced Analytical Testing Laboratories Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>30 Silverline Drive North Brunswick New Jersey 08902 USA </td></tr></table></div>"
},
"identifier" : [
// could also use assigner here, for #74
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3007270600"
}
],
"name" : "Advanced Analytical Testing Laboratories Inc.",
"contact" : [
{
"address" : {
"line" : [
"30 Silverline Drive"
],
"city" : "North Brunswick",
"state" : "New Jersey",
"postalCode" : "08902",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"meta" : // <id value="product"/>
// medicinalproductdefinition-drug-product-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicinalProductDefinition-drug-product-pq.html\">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-local-pq.html\">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
},
"description" : "Textual description of the product",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stelbat Tablets, 20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"resource" : {
"resourceType" : "Ingredient",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6",
"meta" : // id value="productIngredient"/
// ingredient-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Ingredient-drug-pq.html\">Ingredient - Drug Pq</a></p></div><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><p><b>role</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-ingredient-role.html\">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
],
"role" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/ingredient-role",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
}
},
// SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1
{
"fullUrl" : "urn:uuid:57a9af63-315d-1585-a261-0e337b289390",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "57a9af63-315d-1585-a261-0e337b289390",
"meta" : // substancedefinition-component-substance-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"57a9af63-315d-1585-a261-0e337b289390\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html\">SubstanceDefinition - Component Substance Drug PQ</a></p></div><p><b>manufacturer</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
],
"name" : [
// Organization/organization-drug-pq-ex1
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c",
"resource" : {
"resourceType" : "Organization",
"id" : "49d2f0c0-4b28-9271-8aaf-2996a8b9739c",
"meta" : // id value="substance-manufacturer"/
// organization-drug-pq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"49d2f0c0-4b28-9271-8aaf-2996a8b9739c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-drug-pq.html\">Organization - Drug PQ</a></p></div><p><b>identifier</b>: id:\u00a03003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b",
"resource" : {
"resourceType" : "Substance",
"id" : "fc078762-81c5-5656-9744-13c7ad1e595b",
"meta" : // <id value="actual-batch-substance"/>
// substance-dxpq-ex1
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"fc078762-81c5-5656-9744-13c7ad1e595b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Substance-drug-pq.html\">Substance - Drug PQ</a></p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT1"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
},
// SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1
{
"fullUrl" : "urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad",
"resource" : {
"resourceType" : "Substance",
"id" : "cb31d747-2338-88d5-342c-8e9c097e4dad",
"text" : // actual-batch-substance-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"cb31d747-2338-88d5-342c-8e9c097e4dad\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT2"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
},
// SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1
{
"fullUrl" : "urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c",
"resource" : {
"resourceType" : "Substance",
"id" : "1551f97b-6f6d-825e-1fb3-44b0b090808c",
"text" : // actual-batch-substance-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"1551f97b-6f6d-825e-1fb3-44b0b090808c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2019-09-07</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 5 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Development <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133991)</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_49d2f0c0-4b28-9271-8aaf-2996a8b9739c\">See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_57a9af63-315d-1585-a261-0e337b289390\">See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2019-09-07"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 5,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133991",
"display" : "Development"
}
]
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c"
}
}
]
},
// Organization/organization-drug-pq-ex1
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT3"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390"
}
}
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
Links: Table of Contents |
QA Report
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