| Package | hl7.fhir.uv.pharm-quality |
| Type | ImplementationGuide |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/uv/pharm-quality/https://build.fhir.org/ig/HL7/uv-dx-pq/index.html |
| Url | http://hl7.org/fhir/uv/pharm-quality/ImplementationGuide/hl7.fhir.uv.pharm-quality |
| Version | 1.0.0 |
| Status | active |
| Date | 2024-05-08T12:53:57+00:00 |
| Name | PharmaceuticalQualityIndustry |
| Title | Pharmaceutical Quality (Industry) |
| Experimental | False |
| Realm | uv |
| Authority | hl7 |
| Description | This IG is developed for the HL7 International Pharmaceutical Quality (PQ) - Industry Use Case project, sponsored by the Biomedical Research and Regulation Work Group * [Project Proposal: PSS-2137](https://jira.hl7.org/browse/PSS-2137) * [Project Scope Statement: PSS-2145](https://jira.hl7.org/browse/PSS-2145) |
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Note: links and images are rebased to the (stated) source
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/pharm-quality/ImplementationGuide/hl7.fhir.uv.pharm-quality
This IG is developed for the HL7 International Pharmaceutical Quality (PQ) - Industry Use Case project, sponsored by the Biomedical Research and Regulation Work Group
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"description" : "Batch Analysis domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses and CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.",
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"description" : "Batch Formula domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.2 Batch Formula.",
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"groupingId" : "domain-bundle-profiles"
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"reference" : "StructureDefinition/Bundle-drug-product-batch-info-pq",
"display" : "Bundle – Product Batch Information"
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"name" : "Bundle - Product Batch Information",
"description" : "Batch/Lot Information domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses.",
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"display" : "Bundle – Substance Batch Information"
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"name" : "Bundle - Substance Batch Information",
"description" : "Batch/Lot Information domain: This Bundle profile represents the structured data used in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses.",
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"reference" : "StructureDefinition/Bundle-drug-product-compatibility-pq",
"display" : "Bundle - Product Compatibility"
},
"name" : "Bundle - Product Compatibility",
"description" : "Compatibility domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.6 Compatibility.",
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"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-product-composition-pq",
"display" : "Bundle – Product Composition"
},
"name" : "Bundle - Product Composition",
"description" : "Composition domain: This Bundle profile represents the structured data used in CTD section 3.2.P.1 Description and Composition of the Drug Product.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
},
{
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-drug-reference-standards-pq",
"display" : "Bundle – Reference Standards"
},
"name" : "Bundle - Reference Standards",
"description" : "Composition domain: This Bundle profile represents the structured data in CTD sections 3.2.P.6 Reference Standards or Materials and 3.2.S.5 Reference Standards or Materials.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-container-closure-system-pq",
"display" : "Bundle - Container Closure System"
},
"name" : "Bundle - Container Closure System",
"description" : "Container Closure System domain: This Bundle profile represents the structured data in CTD sections 3.2.P.7 Container Closure System and 3.2.S.6 Container Closure System.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-product-specification-pq",
"display" : "Bundle – Product Specification"
},
"name" : "Bundle - Product Specification",
"description" : "Specification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.1 Specification(s).",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-substance-specification-pq",
"display" : "Bundle – Substance Specification"
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"name" : "Bundle - Substance Specification",
"description" : "Specification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-drug-product-pq",
"display" : "Bundle – Drug Product"
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"name" : "Bundle - Drug Product",
"description" : "Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.2 Drug Product.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-product-microbiological-attributes-pq",
"display" : "Bundle – Product Microbiological Attributes"
},
"name" : "Bundle - Product Microbiological Attributes",
"description" : "Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.5 Microbiological Attributes.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-product-excipients-pq",
"display" : "Bundle – Product Excipients"
},
"name" : "Bundle - Product Excipients",
"description" : "Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.P.4 Control of Excipients, subsections 3.2.P.4.5 Excipients of Human or Animal Origin and 3.2.P.4.6 Novel Excipients.",
"isExample" : false,
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-substance-general-properties-pq",
"display" : "Bundle – Substance General Properties"
},
"name" : "Bundle - Substance General Properties",
"description" : "Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.1 General Information, subsection 3.2.S.1.3 General Properties.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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"reference" : {
"reference" : "StructureDefinition/Bundle-drug-substance-characterization-pq",
"display" : "Bundle – Substance Characterization"
},
"name" : "Bundle - Substance Characterization",
"description" : "Identification domain: This Bundle profile represents the structured data used in CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.1 – Elucidation of Structure and Other Characteristics.",
"isExample" : false,
"groupingId" : "domain-bundle-profiles"
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-product-impurities-pq",
"display" : "Bundle - Impurities"
},
"name" : "Bundle - Impurities",
"description" : "Impurities domain: This Bundle profile represents the structured data used in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.5 Characterisation of Impurities and CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.2 Impurities.",
"isExample" : false,
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-product-manufacturing-pq",
"display" : "Bundle - Manufacturing"
},
"name" : "Bundle - Manufacturing",
"description" : "Manufacturing Process domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.2 Description of Manufacturing Process and Process Controls.",
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-organizations-pq",
"display" : "Bundle - Organizations"
},
"name" : "Bundle - Organizations",
"description" : "Organizations domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.1 Manufacturer(s) and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.1 Manufacturer(s).",
"isExample" : false,
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"reference" : {
"reference" : "StructureDefinition/Bundle-product-process-validation-pq",
"display" : "Bundle - Process Validation"
},
"name" : "Bundle - Process Validation",
"description" : "Process Validation domain: This Bundle profile represents the structured data used in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.5 Process Validation and/or Evaluation and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.5 Process Validation and/or Evaluation.",
"isExample" : false,
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],
"reference" : {
"reference" : "StructureDefinition/Bundle-drug-stability-pq",
"display" : "Bundle – Stability"
},
"name" : "Bundle - Stability",
"description" : "Stability Study domain: This Bundle profile represents the structured data used in CTD section 3.2.P.8 Stability, subsection 3.2.P.8.3 Stability Data, and CTD section 3.2.S.7 Stability, subsection 3.2.S.7.3 Stability Data.",
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"reference" : {
"reference" : "Bundle/bundle-analytical-procedure-pq-ex1-prod"
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"name" : "Example: Bundle – Analytical Procedure, product",
"description" : "Example of Bundle – Analytical Procedure for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"
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"groupingId" : "domain-bundle-examples"
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"reference" : {
"reference" : "Bundle/bundle-analytical-procedure-pq-ex2-sub"
},
"name" : "Example: Bundle – Analytical Procedure, substance",
"description" : "Example of Bundle – Analytical Procedure for drug substance.",
"isExample" : true,
"profile" : [
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"reference" : {
"reference" : "Bundle/bundle-batch-analysis-pq-ex1-prod"
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"name" : "Example: Bundle – Batch Analysis, product",
"description" : "Example of Bundle – Batch Analysis for drug product.",
"isExample" : true,
"profile" : [
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],
"reference" : {
"reference" : "Bundle/bundle-batch-analysis-pq-ex2-sub"
},
"name" : "Example: Bundle – Batch Analysis, substance",
"description" : "Example of Bundle – Batch Analysis for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq"
],
"groupingId" : "domain-bundle-examples"
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],
"reference" : {
"reference" : "Bundle/bundle-batch-formula-pq-ex1"
},
"name" : "Example: Bundle - Batch Formula",
"description" : "Example of Bundle - Batch Formula for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-formula-pq"
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"groupingId" : "domain-bundle-examples"
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"valueString" : "Bundle"
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],
"reference" : {
"reference" : "Bundle/bundle-drug-product-batch-info-pq-ex1"
},
"name" : "Example: Bundle – Product Batch Information",
"description" : "Example of Bundle – Product Batch Information.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"
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"reference" : {
"reference" : "Bundle/bundle-drug-substance-batch-info-pq-ex1"
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"name" : "Example: Bundle – Substance Batch Information",
"description" : "Example of Bundle – Substance Batch Information.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq"
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"valueString" : "Bundle"
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],
"reference" : {
"reference" : "Bundle/bundle-drug-product-compatibility-pq-ex1"
},
"name" : "Example: Bundle – Product Compatibility",
"description" : "Example of Bundle – Product Compatibility.",
"isExample" : true,
"profile" : [
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"reference" : {
"reference" : "Bundle/bundle-drug-product-composition-pq-ex1"
},
"name" : "Example: Bundle – Product Composition",
"description" : "Example of Bundle – Product Composition.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-composition-pq"
],
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{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-reference-standards-pq-ex2-sub"
},
"name" : "Example: Bundle – Reference Standards, substance",
"description" : "Example of Bundle – Reference Standards for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-reference-standards-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-container-closure-system-pq-ex1-prod"
},
"name" : "Example: Bundle - Container Closure System, product",
"description" : "Example of Bundle - Container Closure System for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-container-closure-system-pq-ex2-sub"
},
"name" : "Example: Bundle - Container Closure System, substance",
"description" : "Example of Bundle - Container Closure System for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-product-specification-pq-ex1"
},
"name" : "Example: Bundle – Product Specification",
"description" : "Example of Bundle – Product Specification.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-substance-specification-pq-ex1"
},
"name" : "Example: Bundle – Substance Specification",
"description" : "Example of Bundle – Substance Specification.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-product-pq-ex1"
},
"name" : "Example: Bundle – Drug Product",
"description" : "Example of Bundle – Drug Product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-product-microbiological-attributes-pq-ex1"
},
"name" : "Example: Bundle – Product Microbiological Attributes",
"description" : "Example of Bundle – Product Microbiological Attributes.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-microbiological-attributes-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-product-excipients-pq-ex1"
},
"name" : "Example: Bundle – Product Excipients",
"description" : "Example of Bundle – Product Excipients.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-excipients-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-substance-general-properties-pq-ex1"
},
"name" : "Example: Bundle – Substance General Properties",
"description" : "Example of Bundle – Substance General Properties.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-general-properties-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-substance-characterization-pq-ex1"
},
"name" : "Example: Bundle – Substance Characterization",
"description" : "Example of Bundle – Substance Characterization.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-characterization-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-impurities-pq-ex1"
},
"name" : "Example: Bundle - Impurities, product",
"description" : "Example of Bundle - Impurities for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-impurities-pq-ex2-sub"
},
"name" : "Example: Bundle - Impurities, substance",
"description" : "Example of Bundle - Impurities for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-manufacturing-pq-ex1"
},
"name" : "Example: Bundle - Manufacturing, product",
"description" : "Example of Bundle - Manufacturing for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-manufacturing-pq-ex2-sub"
},
"name" : "Example: Bundle - Manufacturing, substance",
"description" : "Example of Bundle - Manufacturing for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-organizations-pq-ex1"
},
"name" : "Example: Bundle - Organizations",
"description" : "Example of Bundle - Organizations for either drug product or drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-organizations-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-process-validation-pq-ex1"
},
"name" : "Example: Bundle - Process Validation, product",
"description" : "Example of Bundle - Process Validation for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-process-validation-pq-ex3-prod-bio"
},
"name" : "Example: Bundle - Process Validation, biologic product",
"description" : "Example of Bundle - Process Validation for biologic drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-product-process-validation-pq-ex2-sub"
},
"name" : "Example: Bundle - Process Validation, substance",
"description" : "Example of Bundle - Process Validation for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-stability-pq-ex1-prod"
},
"name" : "Example: Bundle – Stability, product",
"description" : "Example of Bundle – Stability for drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/bundle-drug-stability-pq-ex2-sub"
},
"name" : "Example: Bundle – Stability, substance",
"description" : "Example of Bundle – Stability for drug substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq"
],
"groupingId" : "domain-bundle-examples"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/ActivityDefinition-test-drug-pq",
"display" : "ActivityDefinition - Test"
},
"name" : "ActivityDefinition - Test",
"description" : "This ActivityDefinition profile represents a set of tests and their acceptance criteria through the contained ObservationDefinition resources.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Composition-drug-pq",
"display" : "Composition - Drug"
},
"name" : "Composition - Drug",
"description" : "This Composition profile represents narrative text necessary for pharmaceutical quality (PQ) data exchange.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/DeviceDefinition-drug-pq",
"display" : "DeviceDefinition - Drug"
},
"name" : "DeviceDefinition - Drug",
"description" : "This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/DiagnosticReport-analysis-drug-pq",
"display" : "DiagnosticReport - Drug Analysis"
},
"name" : "DiagnosticReport - Drug Analysis",
"description" : "This DiagnosticReport profile represents results from a batch analysis, stability study, characterization study, impurities analysis, manufacturing process validation study, etc.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/DocumentReference-drug-pq",
"display" : "DocumentReference - Drug"
},
"name" : "DocumentReference - Drug",
"description" : "This DocumentReference profile references a document of any kind, including a diagram or image, that is necessary for pharmaceutical quality (PQ) data exchange.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Ingredient-drug-pq",
"display" : "Ingredient - Drug"
},
"name" : "Ingredient - Drug",
"description" : "This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/ManufacturedItemDefinition-drug-pq",
"display" : "ManufacturedItemDefinition - Drug"
},
"name" : "ManufacturedItemDefinition - Drug",
"description" : "This ManufacturedItemDefinition profile represents information about the physical packaged medication item, such as a tablet or capsule.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Medication-batch-information-drug-pq",
"display" : "Medication - Batch Information"
},
"name" : "Medication - Batch Information",
"description" : "This Medication profile represents information about the batches that underwent testing or analysis.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/MedicinalProductDefinition-drug-product-pq",
"display" : "MedicinalProductDefinition - Drug Product"
},
"name" : "MedicinalProductDefinition - Drug Product",
"description" : "This MedicinalProductDefinition profile represents information that identifies the drug product.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Observation-test-result-drug-pq",
"display" : "Observation - Test Result"
},
"name" : "Observation - Test Result",
"description" : "This Observation profile represents the result of a specific test defined by an ObservationDefinition resource.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/ObservationDefinition-test-method-drug-pq",
"display" : "ObservationDefinition - Test Method"
},
"name" : "ObservationDefinition - Test Method",
"description" : "This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Organization-drug-pq",
"display" : "Organization - Drug"
},
"name" : "Organization - Drug",
"description" : "This Organization profile represents information about a pharmaceutical company or site that performed drug testing or manufacturing.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/PackagedProductDefinition-drug-pq",
"display" : "PackagedProductDefinition - Drug"
},
"name" : "PackagedProductDefinition - Drug",
"description" : "This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/PlanDefinition-drug-pq",
"display" : "PlanDefinition - Drug"
},
"name" : "PlanDefinition - Drug",
"description" : "This PlanDefinition profile represents a protocol, analytical procedure, manufacturing process, or other workflow definition used in pharmaceutical quality (PQ) data gathering.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Procedure-drug-pq",
"display" : "Procedure - Drug"
},
"name" : "Procedure - Drug",
"description" : "This Procedure profile represents the actual performance of a manufacturing step, so that measurements can be recorded (via Observations), such as the actual “hold time†used, or the “bioburden†at the beginning or end of the step. The Procedure may record which device was used in the performance of a manufacturing step.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Specimen-drug-pq",
"display" : "Specimen - Drug"
},
"name" : "Specimen - Drug",
"description" : "This Specimen profile represents identifying information about an individual specimen (an instance).",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/SpecimenDefinition-drug-pq",
"display" : "SpecimenDefinition - Drug"
},
"name" : "SpecimenDefinition - Drug",
"description" : "This SpecimenDefinition profile represents information about the treatment of a specimen, such as storage conditions and test duration.",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/Substance-drug-pq",
"display" : "Substance - Drug"
},
"name" : "Substance - Drug",
"description" : "This Substance profile represents identifying information about an actual batch of substance (an instance).",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/SubstanceDefinition-component-substance-drug-pq",
"display" : "SubstanceDefinition - Component Drug"
},
"name" : "SubstanceDefinition - Component Drug",
"description" : "This SubstanceDefinition profile represents the chemical or biological details about a substance associated with an active ingredient (molecular weight, molecular formula, stereochemistry, protein or nucleic acid subunits).",
"isExample" : false,
"groupingId" : "building-blocks-1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ActivityDefinition"
}
],
"reference" : {
"reference" : "ActivityDefinition/activitydefinition-test-drug-pq-ex1"
},
"name" : "ActivityDefinition - Test - example 1",
"description" : "Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ActivityDefinition"
}
],
"reference" : {
"reference" : "ActivityDefinition/LyophilizationAct"
},
"name" : "ActivityDefinition - Test - example 2",
"description" : "Example of ActivityDefinition - Test for Lyophilization.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Composition"
}
],
"reference" : {
"reference" : "Composition/composition-drug-pq-formulation"
},
"name" : "Composition - Drug - example, formulation",
"description" : "Example of Composition - Drug for formulation.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Composition"
}
],
"reference" : {
"reference" : "Composition/composition-drug-pq-risk"
},
"name" : "Composition - Drug - example, risk",
"description" : "Example of Composition - Drug for risk.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "DeviceDefinition"
}
],
"reference" : {
"reference" : "DeviceDefinition/devicedefinition-drug-pq-ex1"
},
"name" : "DeviceDefinition - Drug - example",
"description" : "Example of DeviceDefinition - Drug for a Rotating Impeller with 1.5mm screen.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "DiagnosticReport"
}
],
"reference" : {
"reference" : "DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod"
},
"name" : "DiagnosticReport - Drug Analysis - example, stability",
"description" : "Example of DiagnosticReport - Drug Analysis for stability study results report on a drug product.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "DocumentReference"
}
],
"reference" : {
"reference" : "DocumentReference/documentreference-drug-pq-process-flow-diagram"
},
"name" : "DocumentReference - Drug - example",
"description" : "Example of DocumentReference - Drug for process flow diagram.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/ingredient-drug-pq-ex1"
},
"name" : "Ingredient - Drug - example",
"description" : "Example of Ingredient - Drug containing one substance.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ManufacturedItemDefinition"
}
],
"reference" : {
"reference" : "ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex1"
},
"name" : "ManufacturedItemDefinition - Drug - example 1",
"description" : "Example of ManufacturedItemDefinition - Drug for an item contained by a closure system.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ManufacturedItemDefinition"
}
],
"reference" : {
"reference" : "ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex2"
},
"name" : "ManufacturedItemDefinition - Drug - example 2",
"description" : "Example of ManufacturedItemDefinition - Drug for Stelbatolol 5mg tablet.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/medication-batch-information-drug-pq-ex1"
},
"name" : "Medication - Batch Information - example",
"description" : "Example of Medication - Batch Information for actual batch with lot number 33445.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicinalProductDefinition"
}
],
"reference" : {
"reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"name" : "MedicinalProductDefinition - Drug Product - example",
"description" : "Example of MedicinalProductDefinition - Drug Product for Stelbat Tablets, 20mg.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Observation"
}
],
"reference" : {
"reference" : "Observation/observation-test-result-lt25c-i1-description"
},
"name" : "Observation - Test Result - example 1",
"description" : "Example of Observation - Test Result of Degradation Product 'Impurity 1' description from longTerm25X test.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Observation"
}
],
"reference" : {
"reference" : "Observation/observation-test-result-lt25c-i1-degradation-imp1"
},
"name" : "Observation - Test Result - example 2",
"description" : "Example of Observation - Test Result of Degradation Product 'Impurity 1' quality from longTerm25X test.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/longTerm25X"
},
"name" : "ObservationDefinition - Test Method - example 1, longTerm25X",
"description" : "Example of ObservationDefinition - Test Method for longTerm25X test for stability.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/Water"
},
"name" : "ObservationDefinition - Test Method - example 2, Water",
"description" : "Example of ObservationDefinition - Test Method for Water Content test method.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/organization-drug-pq-ex1"
},
"name" : "Organization - Drug - example 1, manufacturer",
"description" : "Example of Organization - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/organization-drug-pq-ex2"
},
"name" : "Organization - Drug - example 2, manufacturer",
"description" : "Example of Organization - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/organization-drug-pq-ex3"
},
"name" : "Organization - Drug - example 3, packaging",
"description" : "Example of Organization - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/organization-drug-pq-ex4"
},
"name" : "Organization - Drug - example 4, packaging",
"description" : "Example of Organization - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/organization-drug-pq-ex5"
},
"name" : "Organization - Drug - example 5, testing lab",
"description" : "Example of Organization - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PackagedProductDefinition"
}
],
"reference" : {
"reference" : "PackagedProductDefinition/packagedproductdefinition-drug-pq-ex1"
},
"name" : "PackagedProductDefinition - Drug - example",
"description" : "Example of PackagedProductDefinition - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PlanDefinition"
}
],
"reference" : {
"reference" : "PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"
},
"name" : "PlanDefinition - Drug - example, validation protocol",
"description" : "Example of PlanDefinition - Drug for validation protocol.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PlanDefinition"
}
],
"reference" : {
"reference" : "PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"
},
"name" : "PlanDefinition - Drug - example, manufacturing plan",
"description" : "Example of PlanDefinition - Drug for manufacturing plan",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PlanDefinition"
}
],
"reference" : {
"reference" : "PlanDefinition/plandefinition-drug-pq-ex3-drug-specification"
},
"name" : "PlanDefinition - Drug - example, drug specification",
"description" : "Example of PlanDefinition - Drug for drug specification.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PlanDefinition"
}
],
"reference" : {
"reference" : "PlanDefinition/plandefinition-drug-pq-ex4-mnf-process"
},
"name" : "PlanDefinition - Drug - example, manufacturing process",
"description" : "Example of PlanDefinition - Drug for manufacturing process.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "PlanDefinition"
}
],
"reference" : {
"reference" : "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"
},
"name" : "PlanDefinition - Drug - example, stability study protocol",
"description" : "Example of PlanDefinition - Drug for stability study protocol.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Procedure"
}
],
"reference" : {
"reference" : "Procedure/procedure-drug-pq-ex1"
},
"name" : "Procedure - Drug - example 1",
"description" : "Example of Procedure - Drug for Media Challenge, Run 1.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Procedure"
}
],
"reference" : {
"reference" : "Procedure/procedure-drug-pq-ex2"
},
"name" : "Procedure - Drug - example 2",
"description" : "Example of Procedure - Drug for Lyophilization Homogeneity.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Specimen"
}
],
"reference" : {
"reference" : "Specimen/specimen-drug-pq-ex1"
},
"name" : "Specimen - Drug - example",
"description" : "Example of Specimen - Drug with collection date/time and processing descriptions.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SpecimenDefinition"
}
],
"reference" : {
"reference" : "SpecimenDefinition/specimendefinition-drug-pq-ex1"
},
"name" : "SpecimenDefinition - Drug - example 1",
"description" : "Example of SpecimenDefinition - Drug for specimen stored at 25°C.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SpecimenDefinition"
}
],
"reference" : {
"reference" : "SpecimenDefinition/specimenDefStoredAt30"
},
"name" : "SpecimenDefinition - Drug - example 2",
"description" : "Example of SpecimenDefinition - Drug for specimen stored at 30°C.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SpecimenDefinition"
}
],
"reference" : {
"reference" : "SpecimenDefinition/specimenDefStoredAt40"
},
"name" : "SpecimenDefinition - Drug - example 3",
"description" : "Example of SpecimenDefinition - Drug for specimen stored at 40°C.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Substance"
}
],
"reference" : {
"reference" : "Substance/substance-drug-pq-ex1"
},
"name" : "Substance - Drug - example",
"description" : "Example of Substance - Drug.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SubstanceDefinition"
}
],
"reference" : {
"reference" : "SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1"
},
"name" : "SubstanceDefinition - Component Drug - example 1",
"description" : "Example of SubstanceDefinition - Component Drug, Stelbatolol.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SubstanceDefinition"
}
],
"reference" : {
"reference" : "SubstanceDefinition/StelbatololAqueousSolution"
},
"name" : "SubstanceDefinition - Component Drug - example 2",
"description" : "Example of SubstanceDefinition - Component Drug, Stelbatolol Aqueous Solution.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SubstanceDefinition"
}
],
"reference" : {
"reference" : "SubstanceDefinition/StelbatololGranules"
},
"name" : "SubstanceDefinition - Component Drug - example 3",
"description" : "Example of SubstanceDefinition - Component Drug, Stelbatolol Granules.",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-actual-yield-pq",
"display" : "Extension - Actual Yield"
},
"name" : "Extension - Actual Yield",
"description" : "The actual weight of a batch",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-actual-yield-unfiltered-pq",
"display" : "Extension - Actual Yield Unfiltered"
},
"name" : "Extension - Actual Yield Unfiltered",
"description" : "The actual weight of a batch, before filtering",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-derived-from-pq",
"display" : "Extension - Batch Derived From"
},
"name" : "Extension - Batch Derived From",
"description" : "A reference to another batch that this batch is derived from",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-designation-pq",
"display" : "Extension - Batch Designation"
},
"name" : "Extension - Batch Designation",
"description" : "A batch's type in terms of its general size",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-number-of-items-pq",
"display" : "Extension - Batch Number of Items"
},
"name" : "Extension - Batch Number of Items",
"description" : "The number of items (e.g., tablets) produced in a manufacturing batch.",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-number-of-full-shelves-pq",
"display" : "Extension - Batch Number of Full Shelves"
},
"name" : "Extension - Batch Number of Full Shelves",
"description" : "The count of full shelves from which batches are selected for testing",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-number-of-partial-shelves-pq",
"display" : "Extension - Batch Number of Partial Shelves"
},
"name" : "Extension - Batch Number of Partial Shelves",
"description" : "The number of partially filled shelves from which batches are selected for testing",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-number-of-vials-pq",
"display" : "Extension - Batch Number of Vials"
},
"name" : "Extension - Batch Number of Vials",
"description" : "The count of vials selected for testing",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-release-date-pq",
"display" : "Extension - Batch Release Date"
},
"name" : "Extension - Batch Release Date",
"description" : "The date when a batch was made available",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-retest-date-pq",
"display" : "Extension - Batch Retest Date"
},
"name" : "Extension - Batch Retest Date",
"description" : "The date that a batch is due to be tested again",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-storage-duration-pq",
"display" : "Extension - Batch Storage Duration"
},
"name" : "Extension - Batch Storage Duration",
"description" : "The length of time for which a batch is stored, before being tested",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-batch-substance-batch-pq",
"display" : "Extension - Batch Substance Batch"
},
"name" : "Extension - Batch Substance Batch",
"description" : "A reference to a substance that this batch consists of",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-container-orientation-pq",
"display" : "Extension - Container Orientation"
},
"name" : "Extension - Container Orientation",
"description" : "The spatial orientation of the container when tested, for instance horizontal or vertical",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-formulation-number-pq",
"display" : "Extension - Formulation Number"
},
"name" : "Extension - Formulation Number",
"description" : "An identifying number for the particular substance formulation in the batch",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-history-of-process-pq",
"display" : "Extension - History of Process"
},
"name" : "Extension - History of Process",
"description" : "A textual description of the previous versions, decisions and development of this process",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-impurity-origin-pq"
},
"name" : "Extension - Impurity Origin",
"description" : "Extension - Impurity Origin",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-manufacturing-participant-pq",
"display" : "Extension - Manufacturing Participant"
},
"name" : "Extension - Manufacturing Participant",
"description" : "A reference to a substance that takes part in a process step",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-manufacturing-process-pq",
"display" : "Extension - Manufacturing Process"
},
"name" : "Extension - Manufacturing Process",
"description" : "A reference to the process of manufacture of this batch (PlanDefinition)",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-medication-definition-pq",
"display" : "Extension - Medication Definition"
},
"name" : "Extension - Medication Definition",
"description" : "The MedicinalProductDefinition that corresponds to a medication",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-novel-excipient-pq",
"display" : "Extension - Novel Excipient"
},
"name" : "Extension - Novel Excipient",
"description" : "Whether or not an excipient (inactive ingredient) in a product is considered 'novel'",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-package-definition-pq",
"display" : "Extension - Package Definition"
},
"name" : "Extension - Package Definition",
"description" : "A reference to the packaging for a medication (PackagedProductDefinition)",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-packaging-date-pq",
"display" : "Extension - Packaging Date"
},
"name" : "Extension - Packaging Date",
"description" : "The date when the batch was packaged",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-packaging-site-pq",
"display" : "Extension - Packaging Site"
},
"name" : "Extension - Packaging Site",
"description" : "The organization that packaged this batch (reference to an Organization)",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-plan-document-reference-pq",
"display" : "Extension - Plan Document Reference"
},
"name" : "Extension - Plan Document Reference",
"description" : "A link to a document or image that describes the process of this plan",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-process-parameters-pq",
"display" : "Extension - Process Parameters"
},
"name" : "Extension - Process Parameters",
"description" : "A property value or setting that this process step must use, e.g., a certain temperature or duration",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-process-step-scale-pq",
"display" : "Extension - Process Step Scale"
},
"name" : "Extension - Process Step Scale",
"description" : "A scale size description that applies to a process step, such as 'production' or 'laboratory'",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-qualified-value-criticality-pq",
"display" : "Extension - Qualified Value Criticality"
},
"name" : "Extension - Qualified Value Criticality",
"description" : "A measure of how important the control value of this process step is",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-qualified-value-display-pq",
"display" : "Extension - Qualified Value Display"
},
"name" : "Extension - Qualified Value Display",
"description" : "A displayable version of a qualified value, formatted for showing to a user",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-qualified-value-target-pq",
"display" : "Extension - Qualified Value Target"
},
"name" : "Extension - Qualified Value Target",
"description" : "A target, desired, amount for a qualified value, from within the allowable range",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-qualified-value-text-pq",
"display" : "Extension - Qualified Value Text"
},
"name" : "Extension - Qualified Value Text",
"description" : "A string based acceptable range description",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-site-utilization-pq",
"display" : "Extension - Site Utilization"
},
"name" : "Extension - Site Utilization",
"description" : "The role that the site performs, in the overall context of manufacturing",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-statistical-model-pq",
"display" : "Extension - Statistical Model"
},
"name" : "Extension - Statistical Model",
"description" : "Information about the statistical model utilized to interpret results",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-substance-property-parameter-pq",
"display" : "Extension - Substance Property Parameter"
},
"name" : "Extension - Substance Property Parameter",
"description" : "A parameter to a substance property, such as the concentration or pH at which the property value applies",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-substance-property-range-pq",
"display" : "Extension - Substance Property Range"
},
"name" : "Extension - Substance Property Range",
"description" : "Allows a characteristic or property to use a range datatype, instead of a single value",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-suitability-for-use-pq",
"display" : "Extension - Suitability For Use"
},
"name" : "Extension - Suitability For Use",
"description" : "Whether an excipient is considered suitable for use in this product or item",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-target-fill-weight-pq",
"display" : "Extension - Target Fill Weight"
},
"name" : "Extension - Target Fill Weight",
"description" : "The desired amount of substance in each item to be made from the batch (e.g., a vial)",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-test-comment-pq",
"display" : "Extension - Test Comment"
},
"name" : "Extension - Test Comment",
"description" : "A textual comment that further describes an aspect of a test requirement",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/Extension-time-point-description-pq",
"display" : "Extension - Time Point Description"
},
"name" : "Extension - Time Point Description",
"description" : "A code that further describes a time point, such as 'delayed start'",
"isExample" : false,
"groupingId" : "extensions1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/accelerated40X"
},
"name" : "accelerated40X",
"description" : "ObservationDefinition - accelerated40X",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/accelerated40Y"
},
"name" : "accelerated40Y",
"description" : "ObservationDefinition - accelerated40Y",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/accelerated40Z"
},
"name" : "accelerated40Z",
"description" : "ObservationDefinition - accelerated40Z",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
],
"groupingId" : "building-blocks-2"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ObservationDefinition"
}
],
"reference" : {
"reference" : "ObservationDefinition/longTerm25Y"
},
"name" : "longTerm25Y",
"description" : "ObservationDefinition - longTerm25Y",
"isExample" : true,
"profile" : [
"http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"
& eference" : "ValueSet/vs-closureTypes-pq"
},
"name" : "Closure Types",
"description" : "This value set contains codes for closure types."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-color-pq"
},
"name" : "Colors",
"description" : "This value set contains codes for drug substance or product color."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-containerOrientation-pq"
},
"name" : "Container Orientations",
"description" : "This value set contains codes for container orientation."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-country-pq"
},
"name" : "ISO Country two letter codes",
"description" : "This value set contains codes for ISO Country two letter codes."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-deviceProperty-pq"
},
"name" : "Device Properties",
"description" : "This value set contains codes for device property."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-deviceType-pq"
},
"name" : "Device Type",
"description" : "This value set contains example codes for device type in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-diagramType-pq"
},
"name" : "Diagram Types",
"description" : "This value set contains codes for diagram type."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-equipmentClass-pq"
},
"name" : "Equipment Classes",
"description" : "This value set contains codes for manufacturing equipment class."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-goalPriority-pq"
},
"name" : "Goal Priority",
"description" : "This value set contains example codes for goal priority used in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-grade-pq"
},
"name" : "Grades",
"description" : "This value set contains codes for package grade."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-impurity-origin-pq"
},
"name" : "Impurity Origins",
"description" : "This value set contains codes for impurity origin."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-impurity-type-pq"
},
"name" : "Impurity Types",
"description" : "This value set contains codes for impurity type."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-ingredientFunction-pq"
},
"name" : "Ingredient Function",
"description" : "This value set contains codes for ingredient function."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-manufactured-item-property-pq"
},
"name" : "Manufactured Item Property",
"description" : "This value set contains example codes for manufactured item property in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-manufacturingParticipantRole-pq"
},
"name" : "Manufacturing Participant Role",
"description" : "This value set contains codes for manufacturing participant."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-manufacturingStep-pq"
},
"name" : "Manufacturing Step",
"description" : "This value set contains codes for manufacturing step."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-manufacturingStepScale-pq"
},
"name" : "Manufacturing Step Scale",
"description" : "This value set contains codes for manufacturing step scale."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-medicinalproduct-characteristic-type"
},
"name" : "MedicinalProduct Characteristic Type",
"description" : "Example codes for MedicinalProduct.characteristic.type"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-medicine-doseform"
},
"name" : "Medicine Dose Form EDQM",
"description" : "EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. This Value Set includes all the EDQM Standard Terms having: \n[Concept Status] = ‘Current’�AND \n[Concept Class] IN (‘PDF’, ‘CMT’, ‘CDF’, ‘PFT') AND \n[Domain] = 'Human and Veterinary' \n\nPDF = 'Pharmaceutical dose form'; CMT = 'Combined terms'; CDF = 'Combined pharmaceutical dose form'; PFT = 'Patient Friendly'"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-medicine-route-of-administration"
},
"name" : "Medicine Route of Administration EDQM",
"description" : "EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. This Value Set includes all the EDQM Standard Terms having: \n[Concept Status] = ‘Current’�AND \n[Concept Class] = 'ROA' AND \n[Domain] = 'Human and Veterinary' \n\nROA = 'Route of administration'"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-packageProperty-pq"
},
"name" : "Package Property",
"description" : "This value set contains codes for package property."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-pharmaceutical-organization-type"
},
"name" : "Pharmaceutical Organization Type",
"description" : "This value set contains codes for pharmaceutical organization types."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-planType-pq"
},
"name" : "Plan Type",
"description" : "This value set contains codes for pharmaceutical plan type."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-process-validation-procedure-pq"
},
"name" : "Process Validation Procedure",
"description" : "This value set contains example process validation procedure codes for use in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-processParameter-pq"
},
"name" : "Process Parameter",
"description" : "This value set contains codes for process parameter."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-productNameType-pq"
},
"name" : "Product Name Type",
"description" : "This value set contains example codes for product name type in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-productSiteUtilizationType-pq"
},
"name" : "Product Site Utilization",
"description" : "This value set contains codes for product site utilization type."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-qualifiedValueCriticality-pq"
},
"name" : "Qualified Value Criticality",
"description" : "This value set contains example codes for observation qualified value criticality."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-reportType-pq"
},
"name" : "Report Type",
"description" : "This value set contains codes for pharmaceutical report type."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-specification-type-pq"
},
"name" : "Specification Type",
"description" : "This value set contains example codes for specification type in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-substance-property-pq"
},
"name" : "Substance Property",
"description" : "This value set contains example codes for substance property types in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-substance-property-value-pq"
},
"name" : "Substance Property Value",
"description" : "This value set contains example codes for substance property values in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-test-method-pq"
},
"name" : "Test Method",
"description" : "This value set contains example codes for test methods in pharmaceutical quality industry."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-testCategory-pq"
},
"name" : "Test Category",
"description" : "This value set contains codes for test category."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/vs-timePointDescription-pq"
},
"name" : "Time Point Description",
"description" : "This value set contains codes for time point description."
}
],
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"name" : "index.html",
"title" : "Home Page",
"generation" : "markdown",
"page" : [
{
"name" : "use_cases.html",
"title" : "Business Use Cases",
"generation" : "markdown"
},
{
"name" : "domains.html",
"title" : "Domains Overview",
"generation" : "markdown",
"page" : [
{
"name" : "anal_proc.html",
"title" : "Analytical Procedures",
"generation" : "markdown",
"page" : [
{
"name" : "anal_proc_rend_p.html",
"title" : "Analytical Procedures: synthetic data rendering - drug product",
"generation" : "markdown"
},
{
"name" : "anal_proc_rend_s.html",
"title" : "Analytical Procedures: synthetic data rendering - drug substance",
"generation" : "markdown"
}
]
},
{
"name" : "batch_anal.html",
"title" : "Batch Analysis",
"generation" : "markdown",
"page" : [
{
"name" : "batch_anal_rend_p.html",
"title" : "Batch Analysis: synthetic data rendering - drug product",
"generation" : "markdown"
},
{
"name" : "batch_anal_rend_s.html",
"title" : "Batch Analysis: synthetic data rendering - drug substance",
"generation" : "markdown"
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},
{
"name" : "batch_formula.html",
"title" : "Batch Formula",
"generation" : "markdown",
"page" : [
{
"name" : "batch_formula_rend_p.html",
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"generation" : "markdown"
}
]
},
{
"name" : "batch_info.html",
"title" : "Batch/Lot Information",
"generation" : "markdown",
"page" : [
{
"name" : "batch_info_rend_p.html",
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{
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"page" : [
{
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},
{
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"generation" : "markdown",
"page" : [
{
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{
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"generation" : "markdown",
"page" : [
{
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{
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{
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"page" : [
{
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{
"name" : "identification_rend_p2.html",
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"generation" : "markdown"
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{
"name" : "identification_rend_p3.html",
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{
"name" : "identification_rend_s2.html",
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"generation" : "markdown"
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{
"name" : "identification_rend_s1.html",
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},
{
"name" : "impurities.html",
"title" : "Impurities",
"generation" : "markdown",
"page" : [
{
"name" : "impurities_rend_p.html",
"title" : "Impurities: synthetic data rendering - drug product",
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{
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"generation" : "markdown",
"page" : [
{
"name" : "mnf_process_rend_p.html",
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"generation" : "markdown"
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{
"name" : "mnf_process_rend_s.html",
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"generation" : "markdown"
}
]
},
{
"name" : "organizations.html",
"title" : "Organizations",
"generation" : "markdown",
"page" : [
{
"name" : "organizations_rend.html",
"title" : "Organizations: synthetic data rendering",
"generation" : "markdown"
}
]
},
{
"name" : "process_valid.html",
"title" : "Process Validation",
"generation" : "markdown",
"page" : [
{
"name" : "process_valid_rend_p.html",
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"generation" : "markdown"
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{
"name" : "process_valid_rend_pb.html",
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"generation" : "markdown"
},
{
"name" : "process_valid_rend_s.html",
"title" : "Process Validation: synthetic data rendering - drug substance",
"generation" : "markdown"
}
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},
{
"name" : "stability.html",
"title" : "Stability Study",
"generation" : "markdown",
"page" : [
{
"name" : "stability_rend_p.html",
"title" : "Stability Study: synthetic data rendering - drug product",
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{
"name" : "stability_rend_s.html",
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}
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}
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},
{
"name" : "general_design.html",
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"generation" : "markdown"
},
{
"name" : "downloads.html",
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"generation" : "markdown"
}
]
},
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{
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{
"code" : {
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{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/container-orientation"
},
{
"code" : {
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},
"value" : "http://terminology.hl7.org/CodeSystem/device-property"
},
{
"code" : {
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},
"value" : "http://terminology.hl7.org/CodeSystem/diagram-type"
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{
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{
"code" : {
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},
"value" : "http://terminology.hl7.org/CodeSystem/impurity-origin"
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{
"code" : {
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{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/ingredient-function"
},
{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"
},
{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/manufacturing-step"
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{
"code" : {
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{
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"value" : "http://terminology.hl7.org/CodeSystem/observation-qualified-value-criticality"
},
{
"code" : {
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},
"value" : "http://terminology.hl7.org/CodeSystem/package-grade"
},
{
"code" : {
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},
{
"code" : {
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},
{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"
},
{
"code" : {
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"value" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"
},
{
"code" : {
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{
"code" : {
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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{
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},
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},
{
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},
"value" : "input/images"
},
{
"code" : {
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"code" : "path-liquid"
},
"value" : "template/liquid"
},
{
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{
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{
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{
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{
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{
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{
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},
{
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"value" : "template-page.html"
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{
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},
"value" : "template-page-md.html"
},
{
"code" : {
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"code" : "apply-contact"
},
"value" : "true"
},
{
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{
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},
"value" : "true"
},
{
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},
"value" : "true"
},
{
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},
{
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{
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},
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},
{
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},
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{
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},
"value" : "true"
},
{
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"code" : "fmm-definition"
},
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},
{
"code" : {
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"code" : "propagate-status"
},
"value" : "true"
},
{
"code" : {
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"code" : "excludelogbinaryformat"
},
"value" : "true"
},
{
"code" : {
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"code" : "tabbed-snapshots"
},
"value" : "true"
},
{
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"code" : "auto-oid-root"
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]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.