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FHIR IG Statistics: PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol

Packagehl7.fhir.uv.pharm-quality
Resource TypePlanDefinition
Idplandefinition-drug-pq-ex1-validation-protocol
FHIR VersionR5
Sourcehttp://hl7.org/fhir/uv/pharm-quality/https://build.fhir.org/ig/HL7/uv-dx-pq/PlanDefinition-plandefinition-drug-pq-ex1-validation-protocol.html
URLhttp://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol
Version1.0.0
Statusactive
Date2024-05-08T12:53:57+00:00
TitleDP PROCESS VALIDATION
Realmuv
Authorityhl7
DescriptionPre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...

Resources that use this resource

No resources found


Resources that this resource uses

No resources found


Narrative

Note: links and images are rebased to the (stated) source

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

Source

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      "action": [
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      "code": {
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        },
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        }
      ]
    },
    {
      "title": "Lyophilization Homogeneity",
      "code": {
        "coding": [
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            "system": "http://terminology.hl7.org/CodeSystem/manufacturing-step",
            "code": "LyophilizationHomogeneityStep",
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          }
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}