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
// Substance Analytical Procedure
{
"resourceType" : "Bundle",
"id" : "bundle-analytical-procedure-pq-ex2-sub",
"meta" : // <id value="substance-analytical-procedure"/>
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "analyticalProcedure",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </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 "analyticalProcedure" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#analytical-procedure "Analytical Procedure")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152\">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</a></p><blockquote><p><b>action</b></p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Optical properties <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#OPTICAL)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: Same as for blue light</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Theory <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#THEORY)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: MIE</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Stir Time <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-processParameter-local-pq.html\">CodeSystem - Process Parameter</a>#STIR)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1 minute</p></blockquote><p><b>title</b>: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Dispersant</span></p><p><b>role</b>: Dispersant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#dispersant)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Calculation</p><p><b>description</b>: The particle size result is calculated automatically by the instrument software for each sample.</p><p><b>code</b>: Calculation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Reporting</p><p><b>description</b>: Report the average value as per specification</p><p><b>code</b>: Reporting <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f",
"title" : "Analytical Procedure",
"type" : // http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "analytical-procedure",
"display" : "Analytical Procedure"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"
},
"action" : [
// SubstanceDefinition/substance1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "OPTICAL",
"display" : "Optical properties"
}
]
}
},
{
"url" : "valueText",
"valueString" : "Same as for blue light"
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "THEORY",
"display" : "Theory"
}
]
}
},
{
"url" : "valueText",
"valueString" : "MIE"
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq",
"extension" : [
{
"url" : "parameter",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq",
"code" : "STIR",
"display" : "Stir Time"
}
]
}
},
{
"url" : "value",
"valueQuantity" : // todo ucum
{
"value" : 1,
"unit" : "minute"
}
}
]
}
],
"title" : "Determination of Particle Size of Stelbat by Laser Diffraction (G1112)",
"participant" : [
// can have device here or as ObsDef.device
{
"typeReference" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8135565f82"
}
}
],
"display" : "Dispersant"
},
"role" : // SubstanceDefinition/dispersant
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "dispersant",
"display" : "Dispersant"
}
]
}
},
{
"typeReference" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"
}
}
],
"display" : "Resulting material"
},
"role" : // SubstanceDefinition/resultingMaterial
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ResultingMaterial",
"display" : "Resulting Material"
}
]
}
}
],
"action" : [
{
"title" : "Sample Preparation",
"action" : [
{
"title" : "Instructions",
"description" : "Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use."
}
]
},
{
"title" : "Sample Analysis",
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"
}
]
},
// ObservationDefinition/ParticleSize
{
"title" : "Sample Calculation",
"description" : "The particle size result is calculated automatically by the instrument software for each sample.",
"code" : {
"text" : "Calculation"
}
},
{
"title" : "Reporting",
"description" : "Report the average value as per specification",
"code" : {
"text" : "Reporting"
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c458791f-7cb8-428e-83f7-8a205f821152",
"text" : // substance1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821152\"> </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 "c458791f-7cb8-428e-83f7-8a205f821152" </p></div><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>"
},
"name" : [
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "9f69ec9c-5fd1-30d2-0790-9e8135565f82",
"text" : // dispersant
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </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 "9f69ec9c-5fd1-30d2-0790-9e8135565f82" </p></div><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Shelf life <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Refer to local laboratory expiration date (may be extended with supporting data) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table><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>0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)</td></tr></table></div>"
},
"property" : [
{
"type" : {
"text" : "Shelf life"
},
"valueCodeableConcept" : {
"text" : "Refer to local laboratory expiration date (may be extended with supporting data)"
}
}
],
"name" : [
{
"name" : "0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)"
}
]
}
},
{
"fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "9f69ec9c-5fd1-30d2-0790-9e8035565f82",
"text" : // resultingMaterial
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </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 "9f69ec9c-5fd1-30d2-0790-9e8035565f82" </p></div><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>Stelbat in dispersant (approximately 10 mg/mL)</td></tr></table></div>"
},
"name" : [
{
"name" : "Stelbat in dispersant (approximately 10 mg/mL)"
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"text" : // ParticleSize
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </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 "12e7e672-40a6-4136-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size</p><p><b>status</b>: active</p><p><b>description</b>: Number of Analyses: 1 replicate for each sample preparation</p><p><b>code</b>: <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>device</b>: <a href=\"#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9495c\">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href=\"#ObservationDefinition_12e7e672-41a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e)</a></li></ul></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"title" : "Particle Size",
"status" : "active",
"description" : "Number of Analyses: 1 replicate for each sample preparation",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
"valueCode" : "unsupported"
}
]
},
"specimen" : [
{
"reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
}
],
"device" : [
// SpecimenDefinition/specimendefinition
{
"reference" : "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c"
}
],
"hasMember" : [
// DeviceDefinition/laser
{
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
// ObservationDefinition/ParticleSizeObscuration
{
"reference" : "ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"
},
// ObservationDefinition/ParticleRI
{
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"
}
]
}
},
// ObservationDefinition/ParticleSizeRSD
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"text" : // ParticleSizeObscuration
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </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 "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Obscuration</p><p><b>status</b>: active</p><p><b>code</b>: Obscuration (%) <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>#Obscuration "Obscuration")</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>10-30 %</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"title" : "Obscuration",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Obscuration",
"display" : "Obscuration"
}
],
"text" : "Obscuration (%)"
},
"qualifiedValue" : [
{
"range" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq",
"valueQuantity" : {
"value" : 15,
"unit" : "%"
}
}
],
"low" : {
"value" : 10,
"unit" : "%"
},
"high" : {
"value" : 30,
"unit" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
"text" : // ParticleRI
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </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 "12e7e672-41a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Particle refractive index</p><p><b>status</b>: active</p><p><b>code</b>: Particle refractive index <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>#Refractive index "Refractive index")</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>1.75-1.75</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e",
"title" : "Particle refractive index",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Refractive index",
"display" : "Refractive index"
}
],
"text" : "Particle refractive index"
},
"qualifiedValue" : [
{
"range" : {
"low" : // unitless
{
"value" : 1.75
},
"high" : // unitless
{
"value" : 1.75
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"text" : // ParticleSizeRSD
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </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 "12e7e672-40a6-4036-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size RSD</p><p><b>status</b>: active</p><p><b>code</b>: Particle Size RSD <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>#Particle Size RSD)</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/12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"title" : "Particle Size RSD",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Particle Size RSD",
"display" : "Particle Size RSD"
}
],
"text" : "Particle Size RSD"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "The %RSD for the D(v, 0.9) must be not more than 15%"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"text" : // specimendefinition
{
"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></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><p><b>description</b>: Number of Preparations: 3</p></div>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"status" : "active",
"description" : "Number of Preparations: 3"
}
},
// http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
{
"fullUrl" : "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c",
"resource" : {
"resourceType" : "DeviceDefinition",
"id" : "82a39a18-91cf-a19d-76c1-a9e8bad9495c",
"text" : // laser
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </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 DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9495c" </p></div><p><b>description</b>: Analyzer with disperser and temperature control accessory, or equivalent</p><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size Analyzer with Laser Diffraction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"description" : "Analyzer with disperser and temperature control accessory, or equivalent",
"classification" : [
{
"type" : {
"text" : "Particle Size Analyzer with Laser Diffraction"
}
}
]
}
}
]
}
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
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