Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundle-drug-product-compatibility-pq-ex1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:1e1e1e1e-1e1e-1e1e-1e1e-1e1e1e1e1e1e"^^xsd:anyURI ; fhir:l <urn:uuid:1e1e1e1e-1e1e-1e1e-1e1e-1e1e1e1e1e1e> ] ; ( fhir:resource <urn:uuid:1e1e1e1e-1e1e-1e1e-1e1e-1e1e1e1e1e1e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:2e2e2e2e-2e2e-2e2e-2e2e-2e2e2e2e2e2e"^^xsd:anyURI ; fhir:l <urn:uuid:2e2e2e2e-2e2e-2e2e-2e2e-2e2e2e2e2e2e> ] ; ( fhir:resource <urn:uuid:2e2e2e2e-2e2e-2e2e-2e2e-2e2e2e2e2e2e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:3e3e3e3e-3e3e-3e3e-3e3e-3e3e3e3e3e3e"^^xsd:anyURI ; fhir:l <urn:uuid:3e3e3e3e-3e3e-3e3e-3e3e-3e3e3e3e3e3e> ] ; ( fhir:resource <urn:uuid:3e3e3e3e-3e3e-3e3e-3e3e-3e3e3e3e3e3e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:4e4e4e4e-4e4e-4e4e-4e4e-4e4e4e4e4e4e"^^xsd:anyURI ; fhir:l <urn:uuid:4e4e4e4e-4e4e-4e4e-4e4e-4e4e4e4e4e4e> ] ; ( fhir:resource <urn:uuid:4e4e4e4e-4e4e-4e4e-4e4e-4e4e4e4e4e4e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:5e5e5e5e-5e5e-5e5e-5e5e-5e5e5e5e5e5e"^^xsd:anyURI ; fhir:l <urn:uuid:5e5e5e5e-5e5e-5e5e-5e5e-5e5e5e5e5e5e> ] ; ( fhir:resource <urn:uuid:5e5e5e5e-5e5e-5e5e-5e5e-5e5e5e5e5e5e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:6e6e6e6e-6e6e-6e6e-6e6e-6e6e6e6e6e6e"^^xsd:anyURI ; fhir:l <urn:uuid:6e6e6e6e-6e6e-6e6e-6e6e-6e6e6e6e6e6e> ] ; ( fhir:resource <urn:uuid:6e6e6e6e-6e6e-6e6e-6e6e-6e6e6e6e6e6e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:7e7e7e7e-7e7e-7e7e-7e7e-7e7e7e7e7e7e"^^xsd:anyURI ; fhir:l <urn:uuid:7e7e7e7e-7e7e-7e7e-7e7e-7e7e7e7e7e7e> ] ; ( fhir:resource <urn:uuid:7e7e7e7e-7e7e-7e7e-7e7e-7e7e7e7e7e7e> ) ] ) . # <urn:uuid:1e1e1e1e-1e1e-1e1e-1e1e-1e1e1e1e1e1e> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "medicinalproductdefinition-drug-product-pq-ex1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_medicinalproductdefinition-drug-product-pq-ex1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1</b></p><a name=\"medicinalproductdefinition-drug-product-pq-ex1\"> </a><a name=\"hcmedicinalproductdefinition-drug-product-pq-ex1\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-MedicinalProductDefinition-drug-product-pq.html\">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>identifier</b>: <code>http://example.org/identifiers/product</code>/PROD-12345</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://standardterms.edqm.eu 10219000}\">Tablet</span></p><p><b>route</b>: <span title=\"Codes:{http://standardterms.edqm.eu 20053000}\">Oral use</span></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ProductName</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol 10mg Tablets</td><td><span title=\"Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq INV}\">Invented Name</span></td></tr></table></div>"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://example.org/identifiers/product"^^xsd:anyURI ; fhir:l <http://example.org/identifiers/product> ] ; fhir:value [ fhir:v "PROD-12345" ] ] ) ; # fhir:combinedPharmaceuticalDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "10219000" ] ; fhir:display [ fhir:v "Tablet" ] ] ) ] ; # fhir:route ( [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ; fhir:l <http://standardterms.edqm.eu> ] ; fhir:code [ fhir:v "20053000" ] ; fhir:display [ fhir:v "Oral use" ] ] ) ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "Stelbatolol 10mg Tablets" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq> ] ; fhir:code [ fhir:v "INV" ] ; fhir:display [ fhir:v "Invented Name" ] ] ) ] ] ) . # <urn:uuid:2e2e2e2e-2e2e-2e2e-2e2e-2e2e2e2e2e2e> a fhir:Medication ; fhir:id [ fhir:v "medication-batch-information-drug-pq-ex1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_medication-batch-information-drug-pq-ex1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Medication medication-batch-information-drug-pq-ex1</b></p><a name=\"medication-batch-information-drug-pq-ex1\"> </a><a name=\"hcmedication-batch-information-drug-pq-ex1\"> </a><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\"/><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 title=\"Codes:\"></span></p><blockquote><p><b>batch</b></p><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p>manufacturingDate</blockquote><p><b>value</b>: 2020-06</p><blockquote><p><b>url</b></p>batchQuantity</blockquote><p><b>value</b>: 100100 tablets</p><blockquote><p><b>url</b></p>batchUtilization</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133990}\">Production</span></p><blockquote><p><b>url</b></p>assignedManufacturer</blockquote><p><b>value</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization AAA Molybdenum Products, Inc.</a></p><p><b>closureSystemDescription</b>: 100 cc HDPE Bottle 2 g desiccant</p><blockquote><p><b>url</b></p>container</blockquote></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Designation PQ</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/batch-designation maximum}\">Maximum</span></p><p><b>Extension - Batch Number of Vials PQ</b>: 3</p><p><b>Extension - Batch Substance Batch PQ</b>: <a href=\"Substance-substance-drug-pq-ex1.html\">Substance </a></p><p><b>Extension - Packaging Date PQ</b>: 2020-08</p><p><b>Extension - Packaging Site PQ</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization AAA Molybdenum Products, Inc.</a></p><p><b>Extension - Actual Yield PQ</b>: 4.81 kg</p><p><b>Extension - Actual Yield Unfiltered PQ</b>: 4.91 kg</p><p><b>Extension Target Fill Weight PQ</b>: 30 g</p><p><b>lotNumber</b>: 33445</p></blockquote></div>"^^rdf:XMLLiteral ] ] ; # fhir:code [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq> ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 ; fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ] ] ] ) ] ; # fhir:batch [ ( fhir:extension [ ( fhir:extension [ fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ; fhir:l fhir:manufacturingDate ] ; fhir:value [ a fhir:DateTime ; fhir:v "2020-06"^^xsd:gYearMonth ] ] [ fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ; fhir:l fhir:batchQuantity ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "100100"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablets" ] ] ] [ fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ; fhir:l fhir:batchUtilization ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ; fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl> ] ; fhir:code [ fhir:v "C133990" ] ; fhir:display [ fhir:v "Commercial" ] ] ) ; fhir:text [ fhir:v "Production" ] ] ] [ fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ; fhir:l fhir:assignedManufacturer ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:Organization/organization-drug-pq-ex1 ; fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ] [ ( fhir:extension [ fhir:url [ fhir:v "closureSystemDescription"^^xsd:anyURI ; fhir:l fhir:closureSystemDescription ] ; fhir:value [ a fhir:String ; fhir:v "100 cc HDPE Bottle 2 g desiccant" ] ] ) ; fhir:url [ fhir:v "container"^^xsd:anyURI ; fhir:l fhir:container ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch> ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq> ] ; fhir:value [ a fhir:DateTime ; fhir:v "2019-09-08"^^xsd:date ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq> ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/batch-designation"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/batch-designation> ] ; fhir:code [ fhir:v "maximum" ] ; fhir:display [ fhir:v "Maximum" ] ] ) ; fhir:text [ fhir:v "Maximum" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq> ] ; fhir:value [ a fhir:PositiveInt ; fhir:v "3"^^xsd:positiveInteger ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq> ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:Substance/substance-drug-pq-ex1 ; fhir:reference [ fhir:v "Substance/substance-drug-pq-ex1" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq> ] ; fhir:value [ a fhir:DateTime ; fhir:v "2020-08"^^xsd:gYearMonth ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq> ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:Organization/organization-drug-pq-ex1 ; fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq> ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v 4.81 ] ; fhir:unit [ fhir:v "kg" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq> ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v 4.91 ] ; fhir:unit [ fhir:v "kg" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq> ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "30"^^xsd:decimal ] ; fhir:unit [ fhir:v "g" ] ] ] ) ; fhir:lotNumber [ fhir:v "33445" ] ] . # <urn:uuid:3e3e3e3e-3e3e-3e3e-3e3e-3e3e3e3e3e3e> a fhir:PlanDefinition ; fhir:id [ fhir:v "plandefinition-drug-pq-ex5-stability-study-protocol"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_plandefinition-drug-pq-ex5-stability-study-protocol\"> </a>\n <table class=\"narrative-table\">\n <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Stability Monitoring Program</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Subject Type</th>\n\n\n\n<td class=\"content-container\"><a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Narrative description of Stability Study</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Type</th>\n\n\n\n<td class=\"content-container\">\n Stability Study Protocol\n\n\n</td>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Action</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Long-Term</td>\n\n\n</tr>\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>25°C/60% RH</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Long-Term)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">Initial</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Timing</th>\n\n\n\n<td class=\"content-container\">Once</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n \n \n \n \n \n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\">PlanDefinition Sub-Action (Parent Action Title: Initial)</th>\n\n\n</tr>\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">XYZ</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Definition</th>\n\n\n\n<td class=\"content-container\"><code>http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90</code></td>\n\n\n</tr>\n\n\n\n\n\n \n \n\n \n \n\n \n \n\n\n\n\n\n<tr>\n <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>\n</tr>\n\n </tbody>\n </table>\n</div>"^^rdf:XMLLiteral ] ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"^^xsd:anyURI ; fhir:l <http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol> ] ; # fhir:title [ fhir:v "Stability Monitoring Program"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type> ] ; fhir:code [ fhir:v "1244588" ] ; fhir:display [ fhir:v "Stability Study Protocol" ] ] ) ] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:l fhir:MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 ; fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ] ] ; # fhir:description [ fhir:v "Narrative description of Stability Study"] ; # fhir:action ( [ fhir:title [ fhir:v "Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg" ] ; ( fhir:action [ fhir:title [ fhir:v "Long-Term" ] ; fhir:description [ fhir:v "25°C/60% RH" ] ; ( fhir:action [ fhir:title [ fhir:v "Initial" ] ; fhir:timing [ a fhir:Timing ; fhir:repeat [ fhir:bounds [ a fhir:Range ; fhir:low [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "mo" ] ] ; fhir:high [ fhir:value [ fhir:v "0"^^xsd:decimal ] ; fhir:unit [ fhir:v "months" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ; fhir:l <http://unitsofmeasure.org> ] ; fhir:code [ fhir:v "mo" ] ] ] ; fhir:frequency [ fhir:v "1"^^xsd:positiveInteger ] ] ] ; ( fhir:action [ fhir:title [ fhir:v "XYZ" ] ; fhir:definition [ a fhir:Canonical ; fhir:v "http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"^^xsd:anyURI ; fhir:l <http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90> ] ] ) ] ) ] ) ] ) . # <urn:uuid:4e4e4e4e-4e4e-4e4e-4e4e-4e4e4e4e4e4e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "Assay"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_Assay\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ObservationDefinition Assay</b></p><a name=\"Assay\"> </a><a name=\"hcAssay\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ObservationDefinition-test-method-drug-pq.html\">ObservationDefinition - Test Method PQ</a></p></div><p><b>status</b>: Active</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example ASSAY}\">Assay</span></p><p><b>method</b>: <span title=\"Codes:\">Assay by UHPLC</span></p></div>"^^rdf:XMLLiteral ] ] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example> ] ; fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] ) ; fhir:text [ fhir:v "Assay" ] ] ; # fhir:method [ fhir:text [ fhir:v "Assay by UHPLC" ] ] . # <urn:uuid:5e5e5e5e-5e5e-5e5e-5e5e-5e5e5e5e5e5e> a fhir:DiagnosticReport ; fhir:id [ fhir:v "diagnosticreport-analysis-drug-pq-stability-prod"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DiagnosticReport_diagnosticreport-analysis-drug-pq-stability-prod\"> </a><p class=\"res-header-id\"><b>Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod</b></p><a name=\"diagnosticreport-analysis-drug-pq-stability-prod\"> </a><a name=\"hcdiagnosticreport-analysis-drug-pq-stability-prod\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-DiagnosticReport-analysis-drug-pq.html\">DiagnosticReport - Analysis Drug PQ</a></p></div><h2><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}\">Stability Study Report - 18 months</span> </h2><table class=\"grid\"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Performer</td><td> <a href=\"Organization-organization-drug-pq-ex1.html\">Organization AAA Molybdenum Products, Inc.</a></td></tr><tr><td>Identifier</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class=\"grid\"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>Flags</b></td><td><b>When For</b></td></tr><tr><td><a href=\"Observation-observation-test-result-longterm25c-initial-1.html\"><span title=\"Codes:\">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>Final</td><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p>\n</div></div>"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy> ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol ; fhir:reference [ fhir:v "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq> ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "information about statistical model utilized to interpret stability study results" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq> ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-orientation"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/container-orientation> ] ; fhir:code [ fhir:v "horizontal" ] ; fhir:display [ fhir:v "horizontal" ] ] ) ; fhir:text [ fhir:v "Horizontal" ] ] ] ) ; # fhir:identifier ( [ fhir:system [ fhir:v "https://eudract.europa.eu/example/identifier"^^xsd:anyURI ; fhir:l <https://eudract.europa.eu/example/identifier> ] ; fhir:value [ fhir:v "ABC1234" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type> ] ; fhir:code [ fhir:v "Stability Study Report - 18 months" ] ; fhir:display [ fhir:v "Stability Study Report - 18 months" ] ] ) ] ; # fhir:effective [ a fhir:DateTime ; fhir:v "2020-12"^^xsd:gYearMonth ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq> ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/time-point-description"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/time-point-description> ] ; fhir:code [ fhir:v "Delayed Start Code" ] ; fhir:display [ fhir:v "Delayed Start Code" ] ] ) ; fhir:text [ fhir:v "Refrigerated delayed testing" ] ] ] ) ] ; # fhir:performer ( [ fhir:l fhir:Organization/organization-drug-pq-ex1 ; fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ; # fhir:result ( [ fhir:l fhir:Observation/observation-test-result-longterm25c-initial-1 ; fhir:reference [ fhir:v "Observation/observation-test-result-longterm25c-initial-1" ] ] ) ; # fhir:conclusion [ fhir:v "The samples have been assessed for initial period; no shelf life determined."] . # <urn:uuid:6e6e6e6e-6e6e-6e6e-6e6e-6e6e6e6e6e6e> a fhir:Observation ; fhir:id [ fhir:v "observation-test-result-longterm25c-initial-1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Observation_observation-test-result-longterm25c-initial-1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Observation observation-test-result-longterm25c-initial-1</b></p><a name=\"observation-test-result-longterm25c-initial-1\"> </a><a name=\"hcobservation-test-result-longterm25c-initial-1\"> </a><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\"/><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-activitydefinition-test-drug-pq-ex1.html\">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</a></p><p><b>status</b>: Final</p><p><b>code</b>: <span title=\"Codes:\">Test Components - Long-term 25C etc - Initial (XYZ)</span></p><p><b>subject</b>: <a href=\"Medication-medication-batch-information-drug-pq-ex1.html\">Medication </a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"Organization-organization-drug-pq-ex1.html\">Organization AAA Molybdenum Products, Inc.</a></p><p><b>specimen</b>: <a href=\"Specimen-specimen-drug-pq-ex1.html\">Specimen</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"Observation-observation-test-result-lt25c-i1-description.html\">Observation Description</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-degradation-imp1.html\">Observation Degradation Products</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-degradation-imp2.html\">Observation Degradation Products</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-degradation-imp3.html\">Observation Degradation Products</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-degradation-imp-unspecified.html\">Observation Degradation Products</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-degradation-imp-total.html\">Observation Degradation Products</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-water.html\">Observation Water Content</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-microbiological.html\">Observation Microbiological Quality</a></li><li><a href=\"Observation-observation-test-result-lt25c-i1-uniformity.html\">Observation Uniformity of dosage units (by weight)</a></li></ul></div>"^^rdf:XMLLiteral ] ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy> ] ; fhir:value [ a fhir:Reference ; fhir:l fhir:ActivityDefinition/activitydefinition-test-drug-pq-ex1 ; fhir:reference [ fhir:v "ActivityDefinition/activitydefinition-test-drug-pq-ex1" ] ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:code [ fhir:text [ fhir:v "Test Components - Long-term 25C etc - Initial (XYZ)" ] ] ; # fhir:subject [ fhir:l fhir:Medication/medication-batch-information-drug-pq-ex1 ; fhir:reference [ fhir:v "Medication/medication-batch-information-drug-pq-ex1" ] ] ; # fhir:effective [ a fhir:DateTime ; fhir:v "2023-01-01T12:00:00Z"^^xsd:dateTime ] ; # fhir:performer ( [ fhir:l fhir:Organization/organization-drug-pq-ex1 ; fhir:reference [ fhir:v "Organization/organization-drug-pq-ex1" ] ] ) ; # fhir:specimen [ fhir:l fhir:Specimen/specimen-drug-pq-ex1 ; fhir:reference [ fhir:v "Specimen/specimen-drug-pq-ex1" ] ] ; # fhir:hasMember ( [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-description ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-description" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-degradation-imp1 ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-degradation-imp1" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-degradation-imp2 ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-degradation-imp2" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-degradation-imp3 ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-degradation-imp3" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-degradation-imp-total ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-degradation-imp-total" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-water ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-water" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-microbiological ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-microbiological" ] ] [ fhir:l fhir:Observation/observation-test-result-lt25c-i1-uniformity ; fhir:reference [ fhir:v "Observation/observation-test-result-lt25c-i1-uniformity" ] ] ) . # <urn:uuid:7e7e7e7e-7e7e-7e7e-7e7e-7e7e7e7e7e7e> a fhir:Organization ; fhir:id [ fhir:v "organization-drug-pq-ex1"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_organization-drug-pq-ex1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization organization-drug-pq-ex1</b></p><a name=\"organization-drug-pq-ex1\"> </a><a name=\"hcorganization-drug-pq-ex1\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-drug-pq.html\">Organization - Drug PQ</a></p></div><p><b>identifier</b>: <a href=\"http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html\" title=\""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."#xD;#xA;#xD;#xA;For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).\">FDA Establishment Identifier</a>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type drug-substance-manufacture}\">Drug Substance Manufacture</span></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>"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ; fhir:l <urn:oid:2.16.840.1.113883.4.82> ] ; fhir:value [ fhir:v "3003040516" ] ] ) ; # fhir:active [ fhir:v true] ; # fhir:type ( [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"^^xsd:anyURI ; fhir:l <http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type> ] ; fhir:code [ fhir:v "drug-substance-manufacture" ] ; fhir:display [ fhir:v "Drug Substance Manufacture" ] ] ) ] ) ; # fhir:name [ fhir:v "AAA Molybdenum Products, Inc."] ; # fhir:contact ( [ fhir:address [ ( fhir:line [ fhir:v "7233 W 116th Pl" ] [ fhir:v "Ste C" ] ) ; fhir:city [ fhir:v "Broomfield" ] ; fhir:state [ fhir:v "Colorado" ] ; fhir:postalCode [ fhir:v "80020" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . #
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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