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 Specification
{
"resourceType" : "Bundle",
"id" : "bundle-drug-product-specification-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex3-drug-specification",
"text" : // <id value="specificationProtocol"/>
// id value="plandefinition-drug-specification-dxpq-ex1"/
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex3-drug-specification\"> </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 "plandefinition-drug-pq-ex3-drug-specification" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION(S) FOR DRUG PRODUCT</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 specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification(s) for Drug Product</p><p><b>code</b>: Overall set of actions <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Release</p><p><b>code</b>: Timing Group <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>timing</b>: Code: Release time</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><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: End of shelf life</p><p><b>code</b>: Timing Group <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>timing</b>: Code: At end of shelf life</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><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
"title" : "SPECIFICATION(S) FOR DRUG PRODUCT",
"status" : "active",
"subjectReference" : // <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
// http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
{
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"description" : "Narrative description of specifications",
"action" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
{
"title" : "Specification(s) for Drug Product",
"code" : // this is then entire thing
{
"text" : "Overall set of actions"
},
"action" : [
{
"title" : "Release",
"code" : {
"text" : "Timing Group"
},
"timingTiming" : {
"code" : {
"text" : "Release time"
}
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"
},
// ObservationDefinition/Description
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"
},
// ObservationDefinition/Identification
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"
},
// ObservationDefinition/Assay
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"
},
// ObservationDefinition/Degradation
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"
},
// ObservationDefinition/Dissolution
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"
},
// ObservationDefinition/Uniformity
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"
},
// ObservationDefinition/Microbiological
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"
}
]
},
// ObservationDefinition/Water
{
"title" : "End of shelf life",
"code" : {
"text" : "Timing Group"
},
"timingTiming" : {
"code" : {
"text" : "At end of shelf life"
}
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"
},
// ObservationDefinition/DescriptionEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"
},
// ObservationDefinition/IdentificationEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"
},
// ObservationDefinition/AssayEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"
},
// ObservationDefinition/DegradationEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"
},
// ObservationDefinition/DissolutionEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"
},
// ObservationDefinition/UniformityEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"
},
// ObservationDefinition/MicrobiologicalEnd
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/91391017-774b-5c77-93fa-642534278851"
}
]
}
]
}
]
}
},
// ObservationDefinition/WaterEnd
{
"fullUrl" : "urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "77e7020a-270c-6bed-2e55-28e9e942546c",
"text" : // Description
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"77e7020a-270c-6bed-2e55-28e9e942546c\"> </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 "77e7020a-270c-6bed-2e55-28e9e942546c" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c</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><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/77e7020a-270c-6bed-2e55-28e9e942546c",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"method" : {
"text" : "Visual inspection"
},
"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:d24ce3cd-213d-4935-97cf-8e2dd03721ec",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "d24ce3cd-213d-4935-97cf-8e2dd03721ec",
"text" : // DescriptionEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d24ce3cd-213d-4935-97cf-8e2dd03721ec\"> </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 "d24ce3cd-213d-4935-97cf-8e2dd03721ec" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec</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/d24ce3cd-213d-4935-97cf-8e2dd03721ec",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
{
"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" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
"text" : // Identification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"0d0ef4cf-242c-1cb1-81c4-c41837ee9a12\"> </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 "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"method" : {
"text" : "ID by UHPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Consistent with the retention time and UV spectrum of the reference standard"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "f77ba972-5ef8-a178-9a5f-fe7f54da7499",
"text" : // IdentificationEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"f77ba972-5ef8-a178-9a5f-fe7f54da7499\"> </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 "f77ba972-5ef8-a178-9a5f-fe7f54da7499" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <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>#IDT)</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/f77ba972-5ef8-a178-9a5f-fe7f54da7499",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "c0f05343-5b98-6073-1a0f-873aaf4f59bc",
"text" : // Assay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"c0f05343-5b98-6073-1a0f-873aaf4f59bc\"> </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 "c0f05343-5b98-6073-1a0f-873aaf4f59bc" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/c0f05343-5b98-6073-1a0f-873aaf4f59bc",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"method" : {
"text" : "Assay by UHPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "95% to 105% of label claim"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
"text" : // AssayEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"f4a74fd3-876e-38ce-021f-04e5a8fb6a3f\"> </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 "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</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/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "a3d4d23a-800a-684a-6a47-fcfe44e06041",
"text" : // Degradation
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"a3d4d23a-800a-684a-6a47-fcfe44e06041\"> </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 "a3d4d23a-800a-684a-6a47-fcfe44e06041" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041</code></p><p><b>title</b>: Degradation Products</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><p><b>method</b>: Degradation products by UHPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>: ?-0.2</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>: ?-0.3</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>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <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 products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-1.4</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/a3d4d23a-800a-684a-6a47-fcfe44e06041",
"title" : "Degradation Products",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP",
"display" : "Degradation Products"
}
]
},
"method" : {
"text" : "Degradation products by UHPLC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.2,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.3,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3"
}
],
"range" : {
"high" : {
"value" : 0.3,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Individual unspecified degradation products"
}
],
"range" : {
"high" : {
"value" : 0.2,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Total degradation products"
}
],
"range" : {
"high" : {
"value" : 1.4,
"unit" : "% w/w"
}
}
}
],
"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:ef72eeb7-211a-3c16-8460-8725ca43584f",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "ef72eeb7-211a-3c16-8460-8725ca43584f",
"text" : // DegradationEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"ef72eeb7-211a-3c16-8460-8725ca43584f\"> </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 "ef72eeb7-211a-3c16-8460-8725ca43584f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f</code></p><p><b>title</b>: Degradation Products</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>: Individual unspecified degradation products <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <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/ef72eeb7-211a-3c16-8460-8725ca43584f",
"title" : "Degradation Products",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
{
"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"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3"
}
],
"range" : {
"high" : {
"value" : 0.4,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Individual unspecified degradation products"
}
],
"range" : {
"high" : {
"value" : 2.3,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Total degradation products"
}
],
"range" : {
"high" : {
"value" : 2.3,
"unit" : "% w/w"
}
}
}
],
"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:bb11322b-9470-4f13-91b5-c8a5253380eb",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "bb11322b-9470-4f13-91b5-c8a5253380eb",
"text" : // Dissolution
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"bb11322b-9470-4f13-91b5-c8a5253380eb\"> </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 "bb11322b-9470-4f13-91b5-c8a5253380eb" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <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>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/bb11322b-9470-4f13-91b5-c8a5253380eb",
"title" : "Dissolution",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Dissolution",
"display" : "Dissolution"
}
],
"text" : "Dissolution"
},
"method" : {
"text" : "Apparatus 2 (paddles), UV measurement"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
"text" : // DissolutionEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea\"> </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 "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <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>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea",
"title" : "Dissolution",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Dissolution",
"display" : "Dissolution"
}
],
"text" : "Dissolution"
},
"method" : {
"text" : "Apparatus 2 (paddles), UV measurement"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
"text" : // Water
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"6ce8ab6d-55e2-0412-5fb1-ab33763f30b1\"> </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 "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1</code></p><p><b>title</b>: Water Content</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><p><b>method</b>: USP <921> <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>?-1.0</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP <921>"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.0,
"unit" : "% w/w"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:91391017-774b-5c77-93fa-642534278851",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "91391017-774b-5c77-93fa-642534278851",
"text" : // WaterEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"91391017-774b-5c77-93fa-642534278851\"> </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 "91391017-774b-5c77-93fa-642534278851" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851</code></p><p><b>title</b>: Water Content</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><p><b>method</b>: USP <921> <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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>?-2.0</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP <921>"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "64972eb3-99ee-7eae-2f63-733e5ae84f71",
"text" : // Microbiological
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"64972eb3-99ee-7eae-2f63-733e5ae84f71\"> </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 "64972eb3-99ee-7eae-2f63-733e5ae84f71" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71</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><p><b>method</b>: Ph Eur <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/64972eb3-99ee-7eae-2f63-733e5ae84f71",
"title" : "Microbiological",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
],
"text" : "Microbiological Quality"
},
"method" : {
"text" : "Ph Eur"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Shall comply with the requirements of the Ph Eur"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "e582e504-36ec-3b50-4043-51bf1147124e",
"text" : // MicrobiologicalEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"e582e504-36ec-3b50-4043-51bf1147124e\"> </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 "e582e504-36ec-3b50-4043-51bf1147124e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e</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><p><b>method</b>: Ph Eur <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/e582e504-36ec-3b50-4043-51bf1147124e",
"title" : "Microbiological",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Microbiological Quality",
"display" : "Microbiological Quality"
}
],
"text" : "Microbiological Quality"
},
"method" : {
"text" : "Ph Eur"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "e7e2fe59-5433-5cc0-84b1-d5f30032790c",
"text" : // Uniformity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"e7e2fe59-5433-5cc0-84b1-d5f30032790c\"> </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 "e7e2fe59-5433-5cc0-84b1-d5f30032790c" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c</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><p><b>method</b>: Weight variation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</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/e7e2fe59-5433-5cc0-84b1-d5f30032790c",
"title" : "Uniformity of dosage",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
{
"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)"
},
"method" : {
"text" : "Weight variation"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Shall comply with the requirements of the harmonised USP/JP/Ph Eur"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "43dbc2a3-00c4-6f79-6b11-63768b412aa3",
"text" : // UniformityEnd
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"43dbc2a3-00c4-6f79-6b11-63768b412aa3\"> </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 "43dbc2a3-00c4-6f79-6b11-63768b412aa3" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3</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/43dbc2a3-00c4-6f79-6b11-63768b412aa3",
"title" : "Uniformity of dosage",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
{
"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" : "As for release"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-pq-ex1
{
"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></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",
"text" : // productIngredient
{
"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></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_c458791f-7cb8-428e-83f7-8a205f821152\">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</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/c458791f-7cb8-428e-83f7-8a205f821152"
}
}
}
}
},
// SubstanceDefinition/substance1
{
"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><p><b>manufacturer</b>: <a href=\"#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d\">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</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/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
"resource" : {
"resourceType" : "Organization",
"id" : "9fe98cfa-9245-8313-0fc5-d15e613b5d6d",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"9fe98cfa-9245-8313-0fc5-d15e613b5d6d\"> </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 "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" </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"
}
}
]
}
}
]
}
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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