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
| Official URL: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol | Version: 1.0.0 | ||||
| Active as of 2026-05-10 | Computable Name: | ||||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.34.1 | |||||
Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies…
| 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 | |
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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