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FHIR-pharm-quality.xml
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<?xml version="1.0" encoding="UTF-8"?>
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/uv/pharm-quality/2024Jan" ciUrl="http://build.fhir.org/ig/HL7/uv-dx-pq" gitUrl="https://github.com/HL7/uv-dx-pq" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" url="http://hl7.org/fhir/uv/pharm-quality">
<version code="current" url="http://build.fhir.org/ig/HL7/uv-dx-pq"/>
<version code="1.0.0-ballot" url="http://hl7.org/fhir/uv/pharm-quality/2024Jan"/>
<artifactPageExtension value="-definitions"/>
<artifactPageExtension value="-examples"/>
<artifactPageExtension value="-mappings"/>
<artifact id="StructureDefinition/ActivityDefinition-test-drug-pq" key="StructureDefinition-ActivityDefinition-test-drug-pq" name="ActivityDefinition - Test"/>
<artifact id="ActivityDefinition/activitydefinition-test-drug-pq-ex1" key="ActivityDefinition-activitydefinition-test-drug-pq-ex1" name="ActivityDefinition - Test - example 1"/>
<artifact id="ActivityDefinition/LyophilizationAct" key="ActivityDefinition-LyophilizationAct" name="ActivityDefinition - Test - example 2"/>
<artifact id="ObservationDefinition/Assay" key="ObservationDefinition-Assay" name="Assay"/>
<artifact id="ValueSet/pqcmc-closure-type-terminology" key="ValueSet-pqcmc-closure-type-terminology" name="Closure Type Terminology"/>
<artifact id="CodeSystem/cs-batch-designation-local-pq" key="CodeSystem-cs-batch-designation-local-pq" name="CodeSystem - Batch Designation"/>
<artifact id="CodeSystem/cs-characterizationStep-local-pq" key="CodeSystem-cs-characterizationStep-local-pq" name="CodeSystem - Characterization Step"/>
<artifact id="CodeSystem/cs-closureTypes-local-pq" key="CodeSystem-cs-closureTypes-local-pq" name="CodeSystem - Closure Types"/>
<artifact id="CodeSystem/cs-color-local-pq" key="CodeSystem-cs-color-local-pq" name="CodeSystem - Color"/>
<artifact id="CodeSystem/cs-containerOrientation-local-pq" key="CodeSystem-cs-containerOrientation-local-pq" name="CodeSystem - Container Orientation"/>
<artifact id="CodeSystem/cs-controlCriticality-local-pq" key="CodeSystem-cs-controlCriticality-local-pq" name="CodeSystem - Control Criticality"/>
<artifact id="CodeSystem/cs-deviceProperty-local-pq" key="CodeSystem-cs-deviceProperty-local-pq" name="CodeSystem - Device Property"/>
<artifact id="CodeSystem/cs-deviceType-local-pq" key="CodeSystem-cs-deviceType-local-pq" name="CodeSystem - Device Type"/>
<artifact id="CodeSystem/cs-diagramType-local-pq" key="CodeSystem-cs-diagramType-local-pq" name="CodeSystem - Diagram Type"/>
<artifact id="CodeSystem/cs-equipmentClass-local-pq" key="CodeSystem-cs-equipmentClass-local-pq" name="CodeSystem - Equipment Class"/>
<artifact id="CodeSystem/cs-local-codes-drug-pq" key="CodeSystem-cs-local-codes-drug-pq" name="CodeSystem - Example Local Codes - Drug"/>
<artifact id="CodeSystem/cs-goalPriority-local-pq" key="CodeSystem-cs-goalPriority-local-pq" name="CodeSystem - Goal Priority"/>
<artifact id="CodeSystem/cs-grade-local-pq" key="CodeSystem-cs-grade-local-pq" name="CodeSystem - Grade"/>
<artifact id="CodeSystem/cs-ich-m7-classification-local-pq" key="CodeSystem-cs-ich-m7-classification-local-pq" name="CodeSystem - ICH M7 Classification"/>
<artifact id="CodeSystem/cs-impurity-origin-local-pq" key="CodeSystem-cs-impurity-origin-local-pq" name="CodeSystem - Impurity Origin"/>
<artifact id="CodeSystem/cs-impurity-type-local-pq" key="CodeSystem-cs-impurity-type-local-pq" name="CodeSystem - Impurity Type"/>
<artifact id="CodeSystem/cs-ingredientFunction-local-pq" key="CodeSystem-cs-ingredientFunction-local-pq" name="CodeSystem - Ingredient Function"/>
<artifact id="CodeSystem/cs-manufactured-item-property-local-pq" key="CodeSystem-cs-manufactured-item-property-local-pq" name="CodeSystem - Manufactured Item Property"/>
<artifact id="CodeSystem/cs-manufacturingParticipantRole-local-pq" key="CodeSystem-cs-manufacturingParticipantRole-local-pq" name="CodeSystem - Manufacturing Participant Role"/>
<artifact id="CodeSystem/cs-manufacturingStep-local-pq" key="CodeSystem-cs-manufacturingStep-local-pq" name="CodeSystem - Manufacturing Step"/>
<artifact id="CodeSystem/cs-manufacturingStepScale-local-pq" key="CodeSystem-cs-manufacturingStepScale-local-pq" name="CodeSystem - Manufacturing Step Scale"/>
<artifact id="CodeSystem/cs-mutagenicity-local-pq" key="CodeSystem-cs-mutagenicity-local-pq" name="CodeSystem - Mutagenicity"/>
<artifact id="CodeSystem/cs-mutagenicityClassificationType-local-pq" key="CodeSystem-cs-mutagenicityClassificationType-local-pq" name="CodeSystem - Mutagenicity Classification Type"/>
<artifact id="CodeSystem/cs-packageProperty-local-pq" key="CodeSystem-cs-packageProperty-local-pq" name="CodeSystem - Package Property"/>
<artifact id="CodeSystem/cs-planType-local-pq" key="CodeSystem-cs-planType-local-pq" name="CodeSystem - Plan Type"/>
<artifact id="CodeSystem/cs-processParameter-local-pq" key="CodeSystem-cs-processParameter-local-pq" name="CodeSystem - Process Parameter"/>
<artifact id="CodeSystem/cs-productNameType-local-pq" key="CodeSystem-cs-productNameType-local-pq" name="CodeSystem - Product Name Type"/>
<artifact id="CodeSystem/cs-productSiteUtilizationType-local-pq" key="CodeSystem-cs-productSiteUtilizationType-local-pq" name="CodeSystem - Product Site Utilization Type"/>
<artifact id="CodeSystem/cs-qualifiedValueCriticality-local-pq" key="CodeSystem-cs-qualifiedValueCriticality-local-pq" name="CodeSystem - Qualified Value Criticality"/>
<artifact id="CodeSystem/cs-reportType-local-pq" key="CodeSystem-cs-reportType-local-pq" name="CodeSystem - Report Type"/>
<artifact id="CodeSystem/cs-specification-type-local-pq" key="CodeSystem-cs-specification-type-local-pq" name="CodeSystem - Specification Type"/>
<artifact id="CodeSystem/cs-substance-property-local-pq" key="CodeSystem-cs-substance-property-local-pq" name="CodeSystem - Substance Property"/>
<artifact id="CodeSystem/cs-substance-property-solubility-local-pq" key="CodeSystem-cs-substance-property-solubility-local-pq" name="CodeSystem - Substance Property Solubility"/>
<artifact id="CodeSystem/cs-substancePropertyType-local-pq" key="CodeSystem-cs-substancePropertyType-local-pq" name="CodeSystem - Substance Property Type"/>
<artifact id="CodeSystem/cs-testCategory-local-pq" key="CodeSystem-cs-testCategory-local-pq" name="CodeSystem - Test Category"/>
<artifact id="CodeSystem/cs-timePointDescription-local-pq" key="CodeSystem-cs-timePointDescription-local-pq" name="CodeSystem - Time Point Description"/>
<artifact id="StructureDefinition/Composition-drug-pq" key="StructureDefinition-Composition-drug-pq" name="Composition - Drug"/>
<artifact id="Composition/composition-drug-pq-formulation" key="Composition-composition-drug-pq-formulation" name="Composition - Drug - example, formulation"/>
<artifact id="Composition/composition-drug-pq-risk" key="Composition-composition-drug-pq-risk" name="Composition - Drug - example, risk"/>
<artifact id="ObservationDefinition/Degradation" key="ObservationDefinition-Degradation" name="Degradation"/>
<artifact id="ObservationDefinition/Description" key="ObservationDefinition-Description" name="Description"/>
<artifact id="StructureDefinition/DeviceDefinition-drug-pq" key="StructureDefinition-DeviceDefinition-drug-pq" name="DeviceDefinition - Drug"/>
<artifact id="DeviceDefinition/devicedefinition-drug-pq-ex1" key="DeviceDefinition-devicedefinition-drug-pq-ex1" name="DeviceDefinition - Drug - example"/>
<artifact id="StructureDefinition/DiagnosticReport-analysis-drug-pq" key="StructureDefinition-DiagnosticReport-analysis-drug-pq" name="DiagnosticReport - Drug Analysis"/>
<artifact id="DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod" key="DiagnosticReport-diagnosticreport-analysis-drug-pq-stability-prod" name="DiagnosticReport - Drug Analysis - example, stability"/>
<artifact id="StructureDefinition/DocumentReference-drug-pq" key="StructureDefinition-DocumentReference-drug-pq" name="DocumentReference - Drug"/>
<artifact id="DocumentReference/documentreference-drug-pq-process-flow-diagram" key="DocumentReference-documentreference-drug-pq-process-flow-diagram" name="DocumentReference - Drug - example"/>
<artifact id="Bundle/bundle-batch-formula-pq-ex1" key="Bundle-bundle-batch-formula-pq-ex1" name="Example: Bundle - Batch Formula"/>
<artifact id="Bundle/bundle-container-closure-system-pq-ex1-prod" key="Bundle-bundle-container-closure-system-pq-ex1-prod" name="Example: Bundle - Container Closure System, product"/>
<artifact id="Bundle/bundle-container-closure-system-pq-ex2-sub" key="Bundle-bundle-container-closure-system-pq-ex2-sub" name="Example: Bundle - Container Closure System, substance"/>
<artifact id="Bundle/bundle-product-impurities-pq-ex1" key="Bundle-bundle-product-impurities-pq-ex1" name="Example: Bundle - Impurities, product"/>
<artifact id="Bundle/bundle-product-impurities-pq-ex2-sub" key="Bundle-bundle-product-impurities-pq-ex2-sub" name="Example: Bundle - Impurities, substance"/>
<artifact id="Bundle/bundle-product-manufacturing-pq-ex1" key="Bundle-bundle-product-manufacturing-pq-ex1" name="Example: Bundle - Manufacturing, product"/>
<artifact id="Bundle/bundle-product-manufacturing-pq-ex2-sub" key="Bundle-bundle-product-manufacturing-pq-ex2-sub" name="Example: Bundle - Manufacturing, substance"/>
<artifact id="Bundle/bundle-organizations-pq-ex1" key="Bundle-bundle-organizations-pq-ex1" name="Example: Bundle - Organizations"/>
<artifact id="Bundle/bundle-product-process-validation-pq-ex3-prod-bio" key="Bundle-bundle-product-process-validation-pq-ex3-prod-bio" name="Example: Bundle - Process Validation, biologic product"/>
<artifact id="Bundle/bundle-product-process-validation-pq-ex1" key="Bundle-bundle-product-process-validation-pq-ex1" name="Example: Bundle - Process Validation, product"/>
<artifact id="Bundle/bundle-product-process-validation-pq-ex2-sub" key="Bundle-bundle-product-process-validation-pq-ex2-sub" name="Example: Bundle - Process Validation, substance"/>
<artifact id="Bundle/bundle-analytical-procedure-pq-ex1-prod" key="Bundle-bundle-analytical-procedure-pq-ex1-prod" name="Example: Bundle – Analytical Procedure, product"/>
<artifact id="Bundle/bundle-analytical-procedure-pq-ex2-sub" key="Bundle-bundle-analytical-procedure-pq-ex2-sub" name="Example: Bundle – Analytical Procedure, substance"/>
<artifact id="Bundle/bundle-batch-analysis-pq-ex1-prod" key="Bundle-bundle-batch-analysis-pq-ex1-prod" name="Example: Bundle – Batch Analysis, product"/>
<artifact id="Bundle/bundle-batch-analysis-pq-ex2-sub" key="Bundle-bundle-batch-analysis-pq-ex2-sub" name="Example: Bundle – Batch Analysis, substance"/>
<artifact id="Bundle/bundle-drug-product-pq-ex1" key="Bundle-bundle-drug-product-pq-ex1" name="Example: Bundle – Drug Product"/>
<artifact id="Bundle/bundle-drug-product-batch-info-pq-ex1" key="Bundle-bundle-drug-product-batch-info-pq-ex1" name="Example: Bundle – Product Batch Information"/>
<artifact id="Bundle/bundle-drug-product-compatibility-pq-ex1" key="Bundle-bundle-drug-product-compatibility-pq-ex1" name="Example: Bundle – Product Compatibility"/>
<artifact id="Bundle/bundle-drug-product-composition-pq-ex1" key="Bundle-bundle-drug-product-composition-pq-ex1" name="Example: Bundle – Product Composition"/>
<artifact id="Bundle/bundle-drug-product-excipients-pq-ex1" key="Bundle-bundle-drug-product-excipients-pq-ex1" name="Example: Bundle – Product Excipients"/>
<artifact id="Bundle/bundle-drug-product-microbiological-attributes-pq-ex1" key="Bundle-bundle-drug-product-microbiological-attributes-pq-ex1" name="Example: Bundle – Product Microbiological Attributes"/>
<artifact id="Bundle/bundle-drug-product-specification-pq-ex1" key="Bundle-bundle-drug-product-specification-pq-ex1" name="Example: Bundle – Product Specification"/>
<artifact id="Bundle/bundle-drug-reference-standards-pq-ex2-sub" key="Bundle-bundle-drug-reference-standards-pq-ex2-sub" name="Example: Bundle – Reference Standards, substance"/>
<artifact id="Bundle/bundle-drug-stability-pq-ex1-prod" key="Bundle-bundle-drug-stability-pq-ex1-prod" name="Example: Bundle – Stability, product"/>
<artifact id="Bundle/bundle-drug-stability-pq-ex2-sub" key="Bundle-bundle-drug-stability-pq-ex2-sub" name="Example: Bundle – Stability, substance"/>
<artifact id="Bundle/bundle-drug-substance-batch-info-pq-ex1" key="Bundle-bundle-drug-substance-batch-info-pq-ex1" name="Example: Bundle – Substance Batch Information"/>
<artifact id="Bundle/bundle-drug-substance-characterization-pq-ex1" key="Bundle-bundle-drug-substance-characterization-pq-ex1" name="Example: Bundle – Substance Characterization"/>
<artifact id="Bundle/bundle-drug-substance-general-properties-pq-ex1" key="Bundle-bundle-drug-substance-general-properties-pq-ex1" name="Example: Bundle – Substance General Properties"/>
<artifact id="Bundle/bundle-drug-substance-specification-pq-ex1" key="Bundle-bundle-drug-substance-specification-pq-ex1" name="Example: Bundle – Substance Specification"/>
<artifact id="StructureDefinition/Extension-actual-yield-pq" key="StructureDefinition-Extension-actual-yield-pq" name="Extension - Actual Yield"/>
<artifact id="StructureDefinition/Extension-actual-yield-unfiltered-pq" key="StructureDefinition-Extension-actual-yield-unfiltered-pq" name="Extension - Actual Yield Unfiltered"/>
<artifact id="StructureDefinition/Extension-batch-derived-from-pq" key="StructureDefinition-Extension-batch-derived-from-pq" name="Extension - Batch Derived From"/>
<artifact id="StructureDefinition/Extension-batch-designation-pq" key="StructureDefinition-Extension-batch-designation-pq" name="Extension - Batch Designation"/>
<artifact id="StructureDefinition/Extension-batch-number-of-full-shelves-pq" key="StructureDefinition-Extension-batch-number-of-full-shelves-pq" name="Extension - Batch Number of Full Shelves"/>
<artifact id="StructureDefinition/Extension-batch-number-of-partial-shelves-pq" key="StructureDefinition-Extension-batch-number-of-partial-shelves-pq" name="Extension - Batch Number of Partial Shelves"/>
<artifact id="StructureDefinition/Extension-batch-number-of-vials-pq" key="StructureDefinition-Extension-batch-number-of-vials-pq" name="Extension - Batch Number of Vials"/>
<artifact id="StructureDefinition/Extension-batch-release-date-pq" key="StructureDefinition-Extension-batch-release-date-pq" name="Extension - Batch Release Date"/>
<artifact id="StructureDefinition/Extension-batch-retest-date-pq" key="StructureDefinition-Extension-batch-retest-date-pq" name="Extension - Batch Retest Date"/>
<artifact id="StructureDefinition/Extension-batch-storage-duration-pq" key="StructureDefinition-Extension-batch-storage-duration-pq" name="Extension - Batch Storage Duration"/>
<artifact id="StructureDefinition/Extension-batch-substance-batch-pq" key="StructureDefinition-Extension-batch-substance-batch-pq" name="Extension - Batch Substance Batch"/>
<artifact id="StructureDefinition/Extension-container-orientation-pq" key="StructureDefinition-Extension-container-orientation-pq" name="Extension - Container Orientation"/>
<artifact id="StructureDefinition/Extension-formulation-number-pq" key="StructureDefinition-Extension-formulation-number-pq" name="Extension - Formulation Number"/>
<artifact id="StructureDefinition/Extension-history-of-process-pq" key="StructureDefinition-Extension-history-of-process-pq" name="Extension - History of Process"/>
<artifact id="StructureDefinition/Extension-impurity-origin-pq" key="StructureDefinition-Extension-impurity-origin-pq" name="Extension - Impurity Origin"/>
<artifact id="StructureDefinition/Extension-manufacturing-participant-pq" key="StructureDefinition-Extension-manufacturing-participant-pq" name="Extension - Manufacturing Participant"/>
<artifact id="StructureDefinition/Extension-manufacturing-process-pq" key="StructureDefinition-Extension-manufacturing-process-pq" name="Extension - Manufacturing Process"/>
<artifact id="StructureDefinition/Extension-medication-definition-pq" key="StructureDefinition-Extension-medication-definition-pq" name="Extension - Medication Definition"/>
<artifact id="StructureDefinition/Extension-novel-excipient-pq" key="StructureDefinition-Extension-novel-excipient-pq" name="Extension - Novel Excipient"/>
<artifact id="StructureDefinition/Extension-package-definition-pq" key="StructureDefinition-Extension-package-definition-pq" name="Extension - Package Definition"/>
<artifact id="StructureDefinition/Extension-packaging-date-pq" key="StructureDefinition-Extension-packaging-date-pq" name="Extension - Packaging Date"/>
<artifact id="StructureDefinition/Extension-packaging-site-pq" key="StructureDefinition-Extension-packaging-site-pq" name="Extension - Packaging Site"/>
<artifact id="StructureDefinition/Extension-plan-document-reference-pq" key="StructureDefinition-Extension-plan-document-reference-pq" name="Extension - Plan Document Reference"/>
<artifact id="StructureDefinition/Extension-process-parameters-pq" key="StructureDefinition-Extension-process-parameters-pq" name="Extension - Process Parameters"/>
<artifact id="StructureDefinition/Extension-process-step-scale-pq" key="StructureDefinition-Extension-process-step-scale-pq" name="Extension - Process Step Scale"/>
<artifact id="StructureDefinition/Extension-qualified-value-criticality-pq" key="StructureDefinition-Extension-qualified-value-criticality-pq" name="Extension - Qualified Value Criticality"/>
<artifact id="StructureDefinition/Extension-qualified-value-display-pq" key="StructureDefinition-Extension-qualified-value-display-pq" name="Extension - Qualified Value Display"/>
<artifact id="StructureDefinition/Extension-qualified-value-target-pq" key="StructureDefinition-Extension-qualified-value-target-pq" name="Extension - Qualified Value Target"/>
<artifact id="StructureDefinition/Extension-qualified-value-text-pq" key="StructureDefinition-Extension-qualified-value-text-pq" name="Extension - Qualified Value Text"/>
<artifact id="StructureDefinition/Extension-site-utilization-pq" key="StructureDefinition-Extension-site-utilization-pq" name="Extension - Site Utilization"/>
<artifact id="StructureDefinition/Extension-statistical-model-pq" key="StructureDefinition-Extension-statistical-model-pq" name="Extension - Statistical Model"/>
<artifact id="StructureDefinition/Extension-substance-property-parameter-pq" key="StructureDefinition-Extension-substance-property-parameter-pq" name="Extension - Substance Property Parameter"/>
<artifact id="StructureDefinition/Extension-substance-property-range-pq" key="StructureDefinition-Extension-substance-property-range-pq" name="Extension - Substance Property Range"/>
<artifact id="StructureDefinition/Extension-suitability-for-use-pq" key="StructureDefinition-Extension-suitability-for-use-pq" name="Extension - Suitability For Use"/>
<artifact id="StructureDefinition/Extension-target-fill-weight-pq" key="StructureDefinition-Extension-target-fill-weight-pq" name="Extension - Target Fill Weight"/>
<artifact id="StructureDefinition/Extension-test-comment-pq" key="StructureDefinition-Extension-test-comment-pq" name="Extension - Test Comment"/>
<artifact id="StructureDefinition/Extension-time-point-description-pq" key="StructureDefinition-Extension-time-point-description-pq" name="Extension - Time Point Description"/>
<artifact id="ObservationDefinition/Identification" key="ObservationDefinition-Identification" name="Identification"/>
<artifact id="ObservationDefinition/Impurities" key="ObservationDefinition-Impurities" name="Impurities"/>
<artifact id="StructureDefinition/Ingredient-drug-pq" key="StructureDefinition-Ingredient-drug-pq" name="Ingredient - Drug"/>
<artifact id="Ingredient/ingredient-drug-pq-ex1" key="Ingredient-ingredient-drug-pq-ex1" name="Ingredient - Drug - example"/>
<artifact id="StructureDefinition/ManufacturedItemDefinition-drug-pq" key="StructureDefinition-ManufacturedItemDefinition-drug-pq" name="ManufacturedItemDefinition - Drug"/>
<artifact id="ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex1" key="ManufacturedItemDefinition-manufactureditemdefinition-drug-pq-ex1" name="ManufacturedItemDefinition - Drug - example 1"/>
<artifact id="ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex2" key="ManufacturedItemDefinition-manufactureditemdefinition-drug-pq-ex2" name="ManufacturedItemDefinition - Drug - example 2"/>
<artifact id="StructureDefinition/Medication-batch-information-drug-pq" key="StructureDefinition-Medication-batch-information-drug-pq" name="Medication - Batch Information"/>
<artifact id="Medication/medication-batch-information-drug-pq-ex1" key="Medication-medication-batch-information-drug-pq-ex1" name="Medication - Batch Information - example"/>
<artifact id="ValueSet/medicinalproduct-characteristic-type" key="ValueSet-medicinalproduct-characteristic-type" name="MedicinalProduct Characteristic Type"/>
<artifact id="StructureDefinition/MedicinalProductDefinition-drug-product-pq" key="StructureDefinition-MedicinalProductDefinition-drug-product-pq" name="MedicinalProductDefinition - Drug Product"/>
<artifact id="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" key="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1" name="MedicinalProductDefinition - Drug Product - example"/>
<artifact id="ValueSet/medicine-doseform" key="ValueSet-medicine-doseform" name="Medicine Dose Form EDQM"/>
<artifact id="ValueSet/medicine-route-of-administration" key="ValueSet-medicine-route-of-administration" name="Medicine Route of Administration EDQM"/>
<artifact id="ObservationDefinition/Microbiological" key="ObservationDefinition-Microbiological" name="Microbiological"/>
<artifact id="StructureDefinition/Observation-test-result-drug-pq" key="StructureDefinition-Observation-test-result-drug-pq" name="Observation - Test Result"/>
<artifact id="Observation/observation-test-result-lt25c-i1-description" key="Observation-observation-test-result-lt25c-i1-description" name="Observation - Test Result - example 1"/>
<artifact id="Observation/observation-test-result-lt25c-i1-degradation-imp1" key="Observation-observation-test-result-lt25c-i1-degradation-imp1" name="Observation - Test Result - example 2"/>
<artifact id="StructureDefinition/ObservationDefinition-test-method-drug-pq" key="StructureDefinition-ObservationDefinition-test-method-drug-pq" name="ObservationDefinition - Test Method"/>
<artifact id="ObservationDefinition/longTerm25X" key="ObservationDefinition-longTerm25X" name="ObservationDefinition - Test Method - example 1, longTerm25X"/>
<artifact id="ObservationDefinition/Water" key="ObservationDefinition-Water" name="ObservationDefinition - Test Method - example 2, Water"/>
<artifact id="StructureDefinition/Organization-drug-pq" key="StructureDefinition-Organization-drug-pq" name="Organization - Drug"/>
<artifact id="Organization/organization-drug-pq-ex1" key="Organization-organization-drug-pq-ex1" name="Organization - Drug - example"/>
<artifact id="StructureDefinition/PackagedProductDefinition-drug-pq" key="StructureDefinition-PackagedProductDefinition-drug-pq" name="PackagedProductDefinition - Drug"/>
<artifact id="PackagedProductDefinition/packagedproductdefinition-drug-pq-ex1" key="PackagedProductDefinition-packagedproductdefinition-drug-pq-ex1" name="PackagedProductDefinition - Drug - example"/>
<artifact id="StructureDefinition/PlanDefinition-drug-pq" key="StructureDefinition-PlanDefinition-drug-pq" name="PlanDefinition - Drug"/>
<artifact id="PlanDefinition/plandefinition-drug-pq-ex3-drug-specification" key="PlanDefinition-plandefinition-drug-pq-ex3-drug-specification" name="PlanDefinition - Drug - example, drug specification"/>
<artifact id="PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan" key="PlanDefinition-plandefinition-drug-pq-ex2-manufacturing-plan" name="PlanDefinition - Drug - example, manufacturing plan"/>
<artifact id="PlanDefinition/plandefinition-drug-pq-ex4-mnf-process" key="PlanDefinition-plandefinition-drug-pq-ex4-mnf-process" name="PlanDefinition - Drug - example, manufacturing process"/>
<artifact id="PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol" key="PlanDefinition-plandefinition-drug-pq-ex5-stability-study-protocol" name="PlanDefinition - Drug - example, stability study protocol"/>
<artifact id="PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol" key="PlanDefinition-plandefinition-drug-pq-ex1-validation-protocol" name="PlanDefinition - Drug - example, validation protocol"/>
<artifact id="StructureDefinition/Procedure-drug-pq" key="StructureDefinition-Procedure-drug-pq" name="Procedure - Drug"/>
<artifact id="Procedure/procedure-drug-pq-ex1" key="Procedure-procedure-drug-pq-ex1" name="Procedure - Drug - example 1"/>
<artifact id="Procedure/procedure-drug-pq-ex2" key="Procedure-procedure-drug-pq-ex2" name="Procedure - Drug - example 2"/>
<artifact id="StructureDefinition/Bundle-analytical-procedure-pq" key="StructureDefinition-Bundle-analytical-procedure-pq" name="Profile: Bundle - Analytical Procedure"/>
<artifact id="StructureDefinition/Bundle-batch-analysis-pq" key="StructureDefinition-Bundle-batch-analysis-pq" name="Profile: Bundle - Batch Analysis"/>
<artifact id="StructureDefinition/Bundle-batch-formula-pq" key="StructureDefinition-Bundle-batch-formula-pq" name="Profile: Bundle - Batch Formula"/>
<artifact id="StructureDefinition/Bundle-container-closure-system-pq" key="StructureDefinition-Bundle-container-closure-system-pq" name="Profile: Bundle - Container Closure System"/>
<artifact id="StructureDefinition/Bundle-drug-product-pq" key="StructureDefinition-Bundle-drug-product-pq" name="Profile: Bundle - Drug Product"/>
<artifact id="StructureDefinition/Bundle-product-impurities-pq" key="StructureDefinition-Bundle-product-impurities-pq" name="Profile: Bundle - Impurities"/>
<artifact id="StructureDefinition/Bundle-product-manufacturing-pq" key="StructureDefinition-Bundle-product-manufacturing-pq" name="Profile: Bundle - Manufacturing"/>
<artifact id="StructureDefinition/Bundle-organizations-pq" key="StructureDefinition-Bundle-organizations-pq" name="Profile: Bundle - Organizations"/>
<artifact id="StructureDefinition/Bundle-product-process-validation-pq" key="StructureDefinition-Bundle-product-process-validation-pq" name="Profile: Bundle - Process Validation"/>
<artifact id="StructureDefinition/Bundle-drug-product-batch-info-pq" key="StructureDefinition-Bundle-drug-product-batch-info-pq" name="Profile: Bundle - Product Batch Information"/>
<artifact id="StructureDefinition/Bundle-drug-product-compatibility-pq" key="StructureDefinition-Bundle-drug-product-compatibility-pq" name="Profile: Bundle - Product Compatibility"/>
<artifact id="StructureDefinition/Bundle-drug-product-composition-pq" key="StructureDefinition-Bundle-drug-product-composition-pq" name="Profile: Bundle - Product Composition"/>
<artifact id="StructureDefinition/Bundle-drug-product-excipients-pq" key="StructureDefinition-Bundle-drug-product-excipients-pq" name="Profile: Bundle - Product Excipients"/>
<artifact id="StructureDefinition/Bundle-drug-product-microbiological-attributes-pq" key="StructureDefinition-Bundle-drug-product-microbiological-attributes-pq" name="Profile: Bundle - Product Microbiological Attributes"/>
<artifact id="StructureDefinition/Bundle-drug-product-specification-pq" key="StructureDefinition-Bundle-drug-product-specification-pq" name="Profile: Bundle - Product Specification"/>
<artifact id="StructureDefinition/Bundle-drug-reference-standards-pq" key="StructureDefinition-Bundle-drug-reference-standards-pq" name="Profile: Bundle - Reference Standards"/>
<artifact id="StructureDefinition/Bundle-drug-stability-pq" key="StructureDefinition-Bundle-drug-stability-pq" name="Profile: Bundle - Stability"/>
<artifact id="StructureDefinition/Bundle-drug-substance-batch-info-pq" key="StructureDefinition-Bundle-drug-substance-batch-info-pq" name="Profile: Bundle - Substance Batch Information"/>
<artifact id="StructureDefinition/Bundle-drug-substance-characterization-pq" key="StructureDefinition-Bundle-drug-substance-characterization-pq" name="Profile: Bundle - Substance Characterization"/>
<artifact id="StructureDefinition/Bundle-drug-substance-general-properties-pq" key="StructureDefinition-Bundle-drug-substance-general-properties-pq" name="Profile: Bundle - Substance General Properties"/>
<artifact id="StructureDefinition/Bundle-drug-substance-specification-pq" key="StructureDefinition-Bundle-drug-substance-specification-pq" name="Profile: Bundle - Substance Specification"/>
<artifact id="StructureDefinition/Specimen-drug-pq" key="StructureDefinition-Specimen-drug-pq" name="Specimen - Drug"/>
<artifact id="Specimen/specimen-drug-pq-ex1" key="Specimen-specimen-drug-pq-ex1" name="Specimen - Drug - example"/>
<artifact id="StructureDefinition/SpecimenDefinition-drug-pq" key="StructureDefinition-SpecimenDefinition-drug-pq" name="SpecimenDefinition - Drug"/>
<artifact id="SpecimenDefinition/specimendefinition-drug-pq-ex1" key="SpecimenDefinition-specimendefinition-drug-pq-ex1" name="SpecimenDefinition - Drug - example 1"/>
<artifact id="SpecimenDefinition/specimenDefStoredAt30" key="SpecimenDefinition-specimenDefStoredAt30" name="SpecimenDefinition - Drug - example 2"/>
<artifact id="SpecimenDefinition/specimenDefStoredAt40" key="SpecimenDefinition-specimenDefStoredAt40" name="SpecimenDefinition - Drug - example 3"/>
<artifact id="StructureDefinition/Substance-drug-pq" key="StructureDefinition-Substance-drug-pq" name="Substance - Drug"/>
<artifact id="Substance/substance-drug-pq-ex1" key="Substance-substance-drug-pq-ex1" name="Substance - Drug - example"/>
<artifact id="StructureDefinition/SubstanceDefinition-component-substance-drug-pq" key="StructureDefinition-SubstanceDefinition-component-substance-drug-pq" name="SubstanceDefinition - Component Drug"/>
<artifact id="SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1" key="SubstanceDefinition-substancedefinition-component-substance-drug-pq-ex1" name="SubstanceDefinition - Component Drug - example 1"/>
<artifact id="SubstanceDefinition/StelbatololAqueousSolution" key="SubstanceDefinition-StelbatololAqueousSolution" name="SubstanceDefinition - Component Drug - example 2"/>
<artifact id="SubstanceDefinition/StelbatololGranules" key="SubstanceDefinition-StelbatololGranules" name="SubstanceDefinition - Component Drug - example 3"/>
<artifact id="ObservationDefinition/Uniformity" key="ObservationDefinition-Uniformity" name="Uniformity"/>
<artifact id="ValueSet/vs-batch-designation-local-pq" key="ValueSet-vs-batch-designation-local-pq" name="ValueSet - Batch Designation"/>
<artifact id="ValueSet/vs-containerOrientation-local-pq" key="ValueSet-vs-containerOrientation-local-pq" name="ValueSet - Container Orientation"/>
<artifact id="ValueSet/vs-deviceProperty-local-pq" key="ValueSet-vs-deviceProperty-local-pq" name="ValueSet - Device Property"/>
<artifact id="ValueSet/vs-deviceType-local-pq" key="ValueSet-vs-deviceType-local-pq" name="ValueSet - Device Type"/>
<artifact id="ValueSet/vs-impurity-origin-local-pq" key="ValueSet-vs-impurity-origin-local-pq" name="ValueSet - Impurity Origin"/>
<artifact id="ValueSet/vs-ingredientFunction-local-pq" key="ValueSet-vs-ingredientFunction-local-pq" name="ValueSet - Ingredient Function"/>
<artifact id="ValueSet/vs-manufactured-item-property-local-pq" key="ValueSet-vs-manufactured-item-property-local-pq" name="ValueSet - Manufactured Item Property"/>
<artifact id="ValueSet/vs-manufacturingStep-local-pq" key="ValueSet-vs-manufacturingStep-local-pq" name="ValueSet - Manufacturing Step"/>
<artifact id="ValueSet/vs-manufacturingStepScale-local-pq" key="ValueSet-vs-manufacturingStepScale-local-pq" name="ValueSet - Manufacturing Step Scale"/>
<artifact id="ValueSet/vs-packageProperty-local-pq" key="ValueSet-vs-packageProperty-local-pq" name="ValueSet - Package Property"/>
<artifact id="ValueSet/vs-planType-local-pq" key="ValueSet-vs-planType-local-pq" name="ValueSet - Plan Type"/>
<artifact id="ValueSet/vs-process-validation-procedure-pq" key="ValueSet-vs-process-validation-procedure-pq" name="ValueSet - Process Validation Procedure"/>
<artifact id="ValueSet/vs-productSiteUtilizationType-local-pq" key="ValueSet-vs-productSiteUtilizationType-local-pq" name="ValueSet - Product Site Utilization"/>
<artifact id="ValueSet/vs-qualifiedValueCriticality-local-pq" key="ValueSet-vs-qualifiedValueCriticality-local-pq" name="ValueSet - Qualified Value Criticality"/>
<artifact id="ValueSet/vs-test-method-local-pq" key="ValueSet-vs-test-method-local-pq" name="ValueSet - Test Method"/>
<artifact id="ValueSet/vs-timePointDescription-local-pq" key="ValueSet-vs-timePointDescription-local-pq" name="ValueSet - Time Point Description"/>
<artifact id="ObservationDefinition/accelerated40X" key="ObservationDefinition-accelerated40X" name="accelerated40X"/>
<artifact id="ObservationDefinition/accelerated40Y" key="ObservationDefinition-accelerated40Y" name="accelerated40Y"/>
<artifact id="ObservationDefinition/accelerated40Z" key="ObservationDefinition-accelerated40Z" name="accelerated40Z"/>
<artifact id="ObservationDefinition/longTerm25Y" key="ObservationDefinition-longTerm25Y" name="longTerm25Y"/>
<artifact id="ObservationDefinition/longTerm25Z" key="ObservationDefinition-longTerm25Z" name="longTerm25Z"/>
<artifact id="ObservationDefinition/longTerm30X" key="ObservationDefinition-longTerm30X" name="longTerm30X"/>
<artifact id="ObservationDefinition/longTerm30Y" key="ObservationDefinition-longTerm30Y" name="longTerm30Y"/>
<artifact id="Observation/observation-test-result-longterm25c-initial-1" key="Observation-observation-test-result-longterm25c-initial-1" name="observation-test-result-longterm25c-initial-1"/>
<artifact id="Observation/observation-test-result-lt25c-i1-degradation-imp-total" key="Observation-observation-test-result-lt25c-i1-degradation-imp-total" name="observation-test-result-lt25c-i1-degradation-imp-total"/>
<artifact id="Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified" key="Observation-observation-test-result-lt25c-i1-degradation-imp-unspecified" name="observation-test-result-lt25c-i1-degradation-imp-unspecified"/>
<artifact id="Observation/observation-test-result-lt25c-i1-degradation-imp2" key="Observation-observation-test-result-lt25c-i1-degradation-imp2" name="observation-test-result-lt25c-i1-degradation-imp2"/>
<artifact id="Observation/observation-test-result-lt25c-i1-degradation-imp3" key="Observation-observation-test-result-lt25c-i1-degradation-imp3" name="observation-test-result-lt25c-i1-degradation-imp3"/>
<artifact id="Observation/observation-test-result-lt25c-i1-microbiological" key="Observation-observation-test-result-lt25c-i1-microbiological" name="observation-test-result-lt25c-i1-microbiological"/>
<artifact id="Observation/observation-test-result-lt25c-i1-uniformity" key="Observation-observation-test-result-lt25c-i1-uniformity" name="observation-test-result-lt25c-i1-uniformity"/>
<artifact id="Observation/observation-test-result-lt25c-i1-water" key="Observation-observation-test-result-lt25c-i1-water" name="observation-test-result-lt25c-i1-water"/>
<page key="NA" name="(NA)"/>
<page key="many" name="(many)"/>
<page key="anal_proc" name="Analytical Procedures">
<otherpage url="anal_proc_rend_p"/>
<otherpage url="anal_proc_rend_s"/>
</page>
<page key="artifacts" name="Artifacts Summary"/>
<page key="batch_anal" name="Batch Analysis">
<otherpage url="batch_anal_rend_p"/>
<otherpage url="batch_anal_rend_s"/>
</page>
<page key="batch_formula" name="Batch Formula">
<otherpage url="batch_formula_rend_p"/>
</page>
<page key="batch_info" name="Batch/Lot Information">
<otherpage url="batch_info_rend_p"/>
<otherpage url="batch_info_rend_s"/>
</page>
<page key="best_practices" name="Best Practices, Resources"/>
<page key="use_cases" name="Business Use Cases"/>
<page key="compatibility" name="Compatibility">
<otherpage url="compatibility_rend_p"/>
</page>
<page key="composition" name="Composition">
<otherpage url="composition_rend_p"/>
<otherpage url="composition_rend_s"/>
</page>
<page key="container" name="Container Closure System">
<otherpage url="container_rend_p"/>
<otherpage url="container_rend_s"/>
</page>
<page key="domains" name="Domains Overview"/>
<page key="downloads" name="Downloads"/>
<page key="drug_specification" name="Drug Specification">
<otherpage url="drug_specification_rend_p"/>
<otherpage url="drug_specification_rend_s"/>
</page>
<page key="index" name="Home Page"/>
<page key="identification" name="Identification">
<otherpage url="identification_rend_p1"/>
<otherpage url="identification_rend_p2"/>
<otherpage url="identification_rend_p3"/>
<otherpage url="identification_rend_s1"/>
<otherpage url="identification_rend_s2"/>
</page>
<page key="impurities" name="Impurities">
<otherpage url="impurities_rend_p"/>
<otherpage url="impurities_rend_s"/>
</page>
<page key="mnf_process" name="Manufacturing Process">
<otherpage url="mnf_process_rend_p"/>
<otherpage url="mnf_process_rend_s"/>
</page>
<page key="organizations" name="Organizations">
<otherpage url="organizations_rend"/>
</page>
<page key="process_valid" name="Process Validation">
<otherpage url="process_valid_rend_p"/>
<otherpage url="process_valid_rend_pb"/>
<otherpage url="process_valid_rend_s"/>
</page>
<page key="stability" name="Stability Study">
<otherpage url="stability_rend_p"/>
<otherpage url="stability_rend_s"/>
</page>
<page key="toc" name="Table of Contents"/>
</specification>