Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1 Profile: SubstanceDefinition - Component Substance Drug PQ status: Active manufacturer: Organization AAA Molybdenum Products, Inc. Names - Name * Stelbatolol Hydrochloride
Generated Narrative: SpecimenDefinition specimendefinition-drug-pq-ex1 Profile: SpecimenDefinition - Drug PQ status: Active typeTested preference: Preferred Handlings - Instruction * 25°C/60% RH
Metadata Title DP PROCESS VALIDATION Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use Description Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... Type Workflow Definition Process Validation PlanDefinition Action Title Formulation Buffer Preparation Process Parameter Step Code Formulation Buffer Preparation Process Parameter Step PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Title Formulation Buffer Preparation Process Parameter Step Code FormulationBufferPreparationProcessParameterStep PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Conclusion Definition http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73 PlanDefinition Action Title Formulation Buffer Preparation Performance Indicator Results Code Formulation Buffer Preparation Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Performance Indicator Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424 PlanDefinition Action Title Thawing and Formulation Process Parameter Results Code Thawing and Formulation Process Parameter Resultss PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Process Parameter Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73 PlanDefinition Action Title Thawing and Formulation Performance Indicator Results Code Thawing and Formulation Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Thawing and Formulation Performance Indicator Results) Title ??? Code ??? PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424 PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Bioburden Reduction Filtration Process Parameter Results Code Bioburden Reduction Filtration Process Parameter Results PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Process Parameter Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Bioburden Reduction Filtration Performance Indicator Results Code Bioburden Reduction Filtration Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434 PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Media Challenge Hold Times Code Media Challenge Hold Times PlanDefinition Sub-Action (Parent Action Title: Media Challenge Hold Times) Code Test Definition http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434 PlanDefinition Action Title Media Challenge Results Code Media Challenge Results PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524 PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524 PlanDefinition Action Title Filtered Formulated Drug Product Performance Indicator Results Code Filtered Formulated Drug Product Performance Indicator Results PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424 PlanDefinition Action Title Fill Weight Summary Code Fill Weight Summary PlanDefinition Sub-Action (Parent Action Title: Fill Weight Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524 PlanDefinition Action Title Filling Homogeneity Quality Attributes Code Filling Homogeneity Quality Attributes PlanDefinition Sub-Action (Parent Action Title: Filling Homogeneity Quality Attributes) Code Conclusion Definition http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424 PlanDefinition Action Title Filling Results Summary Code Filling Results Summary PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524 PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 PlanDefinition Action Title Statistical Evaluation of Homogeneity Data Code Statistical Evaluation of Homogeneity Data PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534 PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524 PlanDefinition Action Title Consistency of the Lyophilization Process Code Consistency of the Lyophilization Process PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72 PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process) Code Definition Definition http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd PlanDefinition Action Title Lyophilization Homogeneity Code Lyophilization Homogeneity Results PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424 PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424 Generated using version 0.5.4 of the sample-content-ig Liquid templates
Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
Formulation Buffer Preparation Process Parameter Step
Formulation Buffer Preparation Performance Indicator Results
Thawing and Formulation Process Parameter Results
Thawing and Formulation Process Parameter Resultss
Thawing and Formulation Performance Indicator Results
Bioburden Reduction Filtration Process Parameter Results
Bioburden Reduction Filtration Performance Indicator Results
Filtered Formulated Drug Product Performance Indicator Results
Statistical Evaluation of Homogeneity Data
Consistency of the Lyophilization Process
Generated Narrative: ObservationDefinition Assay Profile: ObservationDefinition - Test Method PQ status: Active code: Assay method: Assay by UHPLC