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
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@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-batch-info-pq-ex1"] ; # Product Batch Info
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq> ] )
] ; #
fhir:type [ fhir:v "collection"] ; #
fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51> )
] [
fhir:fullUrl [ fhir:v "urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc> )
] [
fhir:fullUrl [ fhir:v "urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06> )
] [
fhir:fullUrl [ fhir:v "urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a> )
] [
fhir:fullUrl [ fhir:v "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07> )
] [
fhir:fullUrl [ fhir:v "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"^^xsd:anyURI ] ;
( fhir:resource <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> ) # Section 1.1 - DP Identification
] ) . # Section 8 - Batch or Lot Information (batch 1 of 3)
<urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51> a fhir:Medication ;
fhir:id [ fhir:v "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"] ; # medication-actual-batch
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33445</td></tr></table></div>"
] ; #
fhir:code [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # todo consider change this be the MID? , MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ] )
] ; #
fhir:batch [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2020-06"^^xsd:gYearMonth ] ] [
fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
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:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C185328" ] ;
fhir:display [ fhir:v "Stability Study" ] ] ) ;
fhir:text [ fhir:v "PPQ / Stability" ] ] ] [
fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a" ] # Organization\/manufacturer ] ] [
fhir:url [ fhir:v "container"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "closureSystemDescription"^^xsd:anyURI ] ;
fhir:value [ fhir:v "100 cc HDPE Bottle 2 g desiccant" ] ] ) ] ) ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
fhir:unit [ fhir:v "kg" ] ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq"^^xsd:anyURI ] ;
fhir:value [ 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:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07" ] # Organization\/packaging ] ] ) ;
fhir:lotNumber [ fhir:v "33445" ]
] . #
<urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc> a fhir:Medication ;
fhir:id [ fhir:v "a9dfda53-734b-045f-7ae4-94a6281d53bc"] ; # medication-actual-batch-2
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33446</td></tr></table></div>"
] ; #
fhir:code [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ] )
] ; #
fhir:batch [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2020-06"^^xsd:gYearMonth ] ] [
fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "100050"^^xsd:decimal ] ;
fhir:unit [ fhir:v "tablets" ] ] ] [
fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C185328" ] ;
fhir:display [ fhir:v "Stability Study" ] ] ) ;
fhir:text [ fhir:v "PPQ / Stability" ] ] ] [
fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a" ] # Organization\/manufacturer ] ] [
fhir:url [ fhir:v "container"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "closureSystemDescription"^^xsd:anyURI ] ;
fhir:value [ fhir:v "100 cc HDPE Bottle 2 g desiccant" ] ] ) ] ) ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
fhir:unit [ fhir:v "kg" ] ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq"^^xsd:anyURI ] ;
fhir:value [ 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:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07" ] # Organization\/packaging ] ] ) ;
fhir:lotNumber [ fhir:v "33446" ]
] . #
<urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06> a fhir:Medication ;
fhir:id [ fhir:v "c6f5fadd-62e6-3a01-93d9-b3b182f67d06"] ; # medication-actual-batch-3
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , </td><td>33447</td></tr></table></div>"
] ; #
fhir:code [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ] )
] ; #
fhir:batch [
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "manufacturingDate"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2020-06"^^xsd:gYearMonth ] ] [
fhir:url [ fhir:v "batchQuantity"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "100125"^^xsd:decimal ] ;
fhir:unit [ fhir:v "tablets" ] ] ] [
fhir:url [ fhir:v "batchUtilization"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C185328" ] ;
fhir:display [ fhir:v "Stability Study" ] ] ) ;
fhir:text [ fhir:v "PPQ / Stability" ] ] ] [
fhir:url [ fhir:v "assignedManufacturer"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a" ] # Organization\/manufacturer ] ] [
fhir:url [ fhir:v "container"^^xsd:anyURI ] ;
( fhir:extension [
fhir:url [ fhir:v "closureSystemDescription"^^xsd:anyURI ] ;
fhir:value [ fhir:v "100 cc HDPE Bottle 2 g desiccant" ] ] ) ] ) ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2019-09-08"^^xsd:date ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq"^^xsd:anyURI ] ;
fhir:value [ 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:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07" ] # Organization\/packaging ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "4.8"^^xsd:decimal ] ;
fhir:unit [ fhir:v "kg" ] ] ] ) ;
fhir:lotNumber [ fhir:v "33447" ]
] . #
<urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a> a fhir:Organization ;
fhir:id [ fhir:v "0102bca4-46c1-a6bf-1025-cd403fee710a"] ; # manufacturer
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"0102bca4-46c1-a6bf-1025-cd403fee710a\"> </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 "0102bca4-46c1-a6bf-1025-cd403fee710a" </p></div><p><b>identifier</b>: id: 3010027650</p><p><b>name</b>: AAA Pharmaceutical, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
] ; #
fhir:identifier ( [
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; # FDA establishment identifier
fhir:value [ fhir:v "3010027650" ]
] ) ; #
fhir:name [ fhir:v "AAA Pharmaceutical, Inc."] ; #
fhir:contact ( [
fhir:address [
( fhir:line [ fhir:v "681 Main Street" ] ) ;
fhir:city [ fhir:v "Lumberton" ] ;
fhir:state [ fhir:v "New Jersey" ] ;
fhir:postalCode [ fhir:v "08048" ] ;
fhir:country [ fhir:v "USA" ] ]
] ) . #
<urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07> a fhir:Organization ;
fhir:id [ fhir:v "378fbe5f-5926-3a5c-4c64-5428df877b07"] ; # packaging
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b07\"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b07" </p></div><p><b>name</b>: MySite</p></div>"
] ; #
fhir:name [ fhir:v "MySite"] . #
<urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> a fhir:MedicinalProductDefinition ;
fhir:id [ fhir:v "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"] ; # medicinalproductdefinition-drug-product-dxpq-ex1
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir: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>"
] ; #
fhir:description [ fhir:v "Textual description of the product"] ; #
fhir:combinedPharmaceuticalDoseForm [
( fhir:coding [
fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10225000" ] ;
fhir:display [ fhir:v "Gastro-resistant tablet" ] ] )
] ; #
fhir:route ( [
( fhir:coding [
fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ;
fhir:code [ fhir:v "20053000" ] ;
fhir:display [ fhir:v "Oral use" ] ] )
] ) ; #
fhir:name ( [
fhir:productName [ fhir:v "Stelbat Tablets, 20mg" ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Proprietary" ] ;
fhir:display [ fhir:v "Proprietary" ] ] ) ] ;
( fhir:part [
fhir:part [ fhir:v "20mg" ] ;
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-name-part-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "StrengthPart" ] ;
fhir:display [ fhir:v "Strength part" ] ] ) ] ] )
] ) . #
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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