Metadata
Title DP PROCESS VALIDATION
Version 1.0.0
Identifier urn:oid:2.16.840.1.113883.4.642.40.41.34.1
Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use
Jurisdiction World
Steward (Publisher) HL7 International / Biomedical Research and Regulation
Steward Contact HL7 International / Biomedical Research and Regulation
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
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