Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
Language: en
Profile: Bundle – Analytical Procedure PQ
Bundle bundle-analytical-procedure-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:10101010-1010-1010-1010-101010101010
Resource SubstanceDefinition:
Language: en
status: Active
manufacturer: Organization AAA Molybdenum Products, Inc.
Names
Name Stelbatolol Hydrochloride
Entry 2 - fullUrl = urn:uuid:20202020-2020-2020-2020-202020202020
Resource SpecimenDefinition:
Language: en
Profile: SpecimenDefinition - Drug PQ
status: Active
typeTested
preference: Preferred
Handlings
Instruction 25°C/60% RH
Entry 3 - fullUrl = urn:uuid:30303030-3030-3030-3030-303030303030
Resource PlanDefinition:
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-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: Formulation Buffer Preparation Process Parameter Step) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73PlanDefinition 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/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424PlanDefinition 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-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73PlanDefinition 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/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424PlanDefinition Sub-Action (Parent Action Title: ???) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434PlanDefinition 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-9c19-949ce1958434PlanDefinition 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-9c19-939ce1958434PlanDefinition Sub-Action (Parent Action Title: Bioburden Reduction Filtration Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434PlanDefinition 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-9c19-949ce1958434PlanDefinition 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-9c19-939ce1958524PlanDefinition Sub-Action (Parent Action Title: Media Challenge Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524PlanDefinition 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-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: Filtered Formulated Drug Product Performance Indicator Results) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424PlanDefinition 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-9c19-939ce2958524PlanDefinition 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-9c19-938ce1958424PlanDefinition 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-9c19-939ce1958524PlanDefinition Sub-Action (Parent Action Title: Filling Results Summary) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524PlanDefinition 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-9c19-939ce1958534PlanDefinition Sub-Action (Parent Action Title: Statistical Evaluation of Homogeneity Data) Code Test Definition http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524PlanDefinition 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/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72PlanDefinition Sub-Action (Parent Action Title: Consistency of the Lyophilization Process) Code Definition Definition http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bdPlanDefinition 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-9c19-938ce1958424PlanDefinition Sub-Action (Parent Action Title: Lyophilization Homogeneity) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424Generated using version 0.5.4 of the sample-content-ig Liquid templates
Entry 4 - fullUrl = urn:uuid:40404040-4040-4040-4040-404040404040
Resource ObservationDefinition:
Language: en
status: Active
code: Assay
method: Assay by UHPLC
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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