Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Example PlanDefinition: PlanDefinition - Drug - example, validation protocol

Active as of 2024-05-08

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex1-validation-protocol"

Profile: PlanDefinition - Drug PQ

url: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol

identifier: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.1

version: 1.0.0

title: DP PROCESS VALIDATION

type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation")

status: active

subject: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

date: 2024-05-08 12:53:57+0000

publisher: HL7 International / Biomedical Research and Regulation

contact: HL7 International - Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim

description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...

jurisdiction: World (m49.htm#001)

action

title: Formulation Buffer Preparation Process Parameter Step

code: Formulation Buffer Preparation Process Parameter Step (Manufacturing Step Codes#FormulationBufferPreparationProcessParameterStep)

action

title: Formulation Buffer Preparation Process Parameter Step

code: FormulationBufferPreparationProcessParameterStep ()

action

action

action

action

title: Formulation Buffer Preparation Performance Indicator Results

code: Formulation Buffer Preparation Performance Indicator Results (Manufacturing Step Codes#FormulationBufferPreparationPerformanceIndicatorStep)

action

title: ???

code: ??? ()

action

action

action

action

action

action

title: Thawing and Formulation Process Parameter Results

code: Thawing and Formulation Process Parameter Resultss (Manufacturing Step Codes#ThawingandFormulationProcessParameterResultsStep)

action

title: ???

code: ??? ()

action

action

action

action

action

title: Thawing and Formulation Performance Indicator Results

code: Thawing and Formulation Performance Indicator Results (Manufacturing Step Codes#ThawingandFormulationPerformanceIndicatorResultsStep)

action

title: ???

code: ??? ()

action

action

action

action

action

action

title: Bioburden Reduction Filtration Process Parameter Results

code: Bioburden Reduction Filtration Process Parameter Results (Manufacturing Step Codes#BioburdenReductionFiltrationProcessParameterResultsStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434

action

title: Bioburden Reduction Filtration Performance Indicator Results

code: Bioburden Reduction Filtration Performance Indicator Results (Manufacturing Step Codes#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434
*Test ()http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434

action

title: Media Challenge Hold Times

code: Media Challenge Hold Times (Manufacturing Step Codes#MediaChallengeHoldTimesStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

action

title: Media Challenge Results

code: Media Challenge Results (Manufacturing Step Codes#MediaChallengeResultsStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524
*Test ()http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

action

title: Filtered Formulated Drug Product Performance Indicator Results

code: Filtered Formulated Drug Product Performance Indicator Results (Manufacturing Step Codes#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
*Test ()http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424
*Test ()http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

action

title: Fill Weight Summary

code: Fill Weight Summary (Manufacturing Step Codes#FillWeightSummaryStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

action

title: Filling Homogeneity Quality Attributes

code: Filling Homogeneity Quality Attributes (Manufacturing Step Codes#FillingHomogeneityQualityAttributesStep)

Actions

-CodeDefinition[x]
*Conclusion ()http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424

action

title: Filling Results Summary

code: Filling Results Summary (Manufacturing Step Codes#FillingResultsSummaryStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524
*Test ()http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

action

title: Statistical Evaluation of Homogeneity Data

code: Statistical Evaluation of Homogeneity Data (Manufacturing Step Codes#StatisticalEvaluationOfHomogeneityDataStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534
*Test ()http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

action

title: Consistency of the Lyophilization Process

code: Consistency of the Lyophilization Process (Manufacturing Step Codes#ConsistencyoftheLyophilizationProcessStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72
*Definition ()Lyophilization

action

title: Lyophilization Homogeneity

code: Lyophilization Homogeneity Results (Manufacturing Step Codes#LyophilizationHomogeneityStep)

Actions

-CodeDefinition[x]
*Test ()http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424
*Test ()http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424