bundle-analytical-procedure-pq-ex1
type: Bundle
node role: treeRoot
id:
  v: bundle-analytical-procedure-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq
    l: Bundle-analytical-procedure-pq
language:
  v: en
type:
  v: collection
entry:
  full url:
    v: urn:uuid:10101010-1010-1010-1010-101010101010
    l: 10101010-1010-1010-1010-101010101010
  resource: 10101010-1010-1010-1010-101010101010
entry:
  full url:
    v: urn:uuid:20202020-2020-2020-2020-202020202020
    l: 20202020-2020-2020-2020-202020202020
  resource: 20202020-2020-2020-2020-202020202020
entry:
  full url:
    v: urn:uuid:30303030-3030-3030-3030-303030303030
    l: 30303030-3030-3030-3030-303030303030
  resource: 30303030-3030-3030-3030-303030303030
entry:
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  resource: 40404040-4040-4040-4040-404040404040

10101010-1010-1010-1010-101010101010
type: SubstanceDefinition
id:
  v: substancedefinition-component-substance-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
    l: SubstanceDefinition-component-substance-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1 Profile: SubstanceDefinition - Component Substance Drug PQ status: Active manufacturer: Organization AAA Molybdenum Products, Inc. Names - Name * Stelbatolol Hydrochloride
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
manufacturer:
  l: organization-drug-pq-ex1
  reference:
    v: Organization/organization-drug-pq-ex1
name:
  name:
    v: Stelbatolol Hydrochloride

20202020-2020-2020-2020-202020202020
type: SpecimenDefinition
id:
  v: specimendefinition-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq
    l: SpecimenDefinition-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SpecimenDefinition specimendefinition-drug-pq-ex1 Profile: SpecimenDefinition - Drug PQ status: Active typeTested preference: Preferred Handlings - Instruction * 25°C/60% RH
status:
  v: active
type tested:
  preference:
    v: preferred
  handling:
    instruction:
      v: 25°C/60% RH

30303030-3030-3030-3030-303030303030
type: PlanDefinition
id:
  v: plandefinition-drug-pq-ex1-validation-protocol
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
    l: PlanDefinition-drug-pq
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: 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-9c19-938ce1958424 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-…
url:
  v: http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol
  l: plandefinition-drug-pq-ex1-validation-protocol
title:
  v: DP PROCESS VALIDATION
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
      l: plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type
      l: pharmaceutical-plan-type
    code:
      v: process-validation
    display:
      v: Process Validation
status:
  v: active
subject: Reference
  l: medicinalproductdefinition-drug-product-pq-ex1
  reference:
    v: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
description:
  v: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
action:
  title:
    v: Formulation Buffer Preparation Process Parameter Step
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: FormulationBufferPreparationProcessParameterStep
      display:
        v: Formulation Buffer Preparation Process Parameter Step
    text:
      v: Formulation Buffer Preparation Process Parameter Step
  action:
    title:
      v: Formulation Buffer Preparation Process Parameter Step
    code:
      text:
        v: FormulationBufferPreparationProcessParameterStep
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73
action:
  title:
    v: Formulation Buffer Preparation Performance Indicator Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: FormulationBufferPreparationPerformanceIndicatorStep
      display:
        v: Formulation Buffer Preparation Performance Indicator Results
  action:
    title:
      v: ???
    code:
      text:
        v: ???
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424
action:
  title:
    v: Thawing and Formulation Process Parameter Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: ThawingandFormulationProcessParameterResultsStep
      display:
        v: Thawing and Formulation Process Parameter Resultss
  action:
    title:
      v: ???
    code:
      text:
        v: ???
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73
action:
  title:
    v: Thawing and Formulation Performance Indicator Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: ThawingandFormulationPerformanceIndicatorResultsStep
      display:
        v: Thawing and Formulation Performance Indicator Results
  action:
    title:
      v: ???
    code:
      text:
        v: ???
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424
    action:
      definition: Canonical
        v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434
action:
  title:
    v: Bioburden Reduction Filtration Process Parameter Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: BioburdenReductionFiltrationProcessParameterResultsStep
      display:
        v: Bioburden Reduction Filtration Process Parameter Results
  action:
    code:
      text:
        v: Test
    definition: Canonical
      v: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434
action:
  title:
    v: Bioburden Reduction Filtration Performance Indicator Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
        l: manufacturing-step
      code:
        v: BioburdenReductionFiltrationPerformanceIndicatorResultsStep
      display:
        v: Bioburden Reduction Filtration Performance Indicator Results
  action:
    code:
      text:
        v: Test
    definition: Canonical

40404040-4040-4040-4040-404040404040
type: ObservationDefinition
id:
  v: Assay
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    l: ObservationDefinition-test-method-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ObservationDefinition Assay Profile: ObservationDefinition - Test Method PQ status: Active code: Assay method: Assay by UHPLC
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      l: cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay
method:
  text:
    v: Assay by UHPLC

v: Conclusion

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

code:
  text:
    v: Test
definition: Canonical
  v: http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434

title:
  v: Media Challenge Hold Times
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: MediaChallengeHoldTimesStep
    display:
      v: Media Challenge Hold Times
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434

title:
  v: Media Challenge Results
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: MediaChallengeResultsStep
    display:
      v: Media Challenge Results
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524

title:
  v: Filtered Formulated Drug Product Performance Indicator Results
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: FilteredFormulatedDrugProductPerformanceIndicatorResultsStep
    display:
      v: Filtered Formulated Drug Product Performance Indicator Results
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424

title:
  v: Fill Weight Summary
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: FillWeightSummaryStep
    display:
      v: Fill Weight Summary
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524

title:
  v: Filling Homogeneity Quality Attributes
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: FillingHomogeneityQualityAttributesStep
    display:
      v: Filling Homogeneity Quality Attributes
  text:
    v: Filling Homogeneity Quality Attributes
action:
  code:
    text:
      v: Conclusion
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424

title:
  v: Filling Results Summary
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: FillingResultsSummaryStep
    display:
      v: Filling Results Summary
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

title:
  v: Statistical Evaluation of Homogeneity Data
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: StatisticalEvaluationOfHomogeneityDataStep
    display:
      v: Statistical Evaluation of Homogeneity Data
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524

title:
  v: Consistency of the Lyophilization Process
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: ConsistencyoftheLyophilizationProcessStep
    display:
      v: Consistency of the Lyophilization Process
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72
action:
  code:
    text:
      v: Definition
  definition: Canonical
    v: http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd

title:
  v: Lyophilization Homogeneity
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      l: manufacturing-step
    code:
      v: LyophilizationHomogeneityStep
    display:
      v: Lyophilization Homogeneity Results
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424
action:
  code:
    text:
      v: Test
  definition: Canonical
    v: http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424