bundle-product-process-validation-pq-ex1
type: Bundle
node role: treeRoot
id:
  v: bundle-product-process-validation-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq
    l: Bundle-product-process-validation-pq
language:
  v: en
type:
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1h1h1h1h-1h1h-1h1h-1h1h-1h1h1h1h1h1h
type: MedicinalProductDefinition
id:
  v: medicinalproductdefinition-drug-product-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq
    l: MedicinalProductDefinition-drug-product-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1 Profile: MedicinalProductDefinition - Drug Product PQ identifier: http://example.org/identifiers/product/PROD-12345 combinedPharmaceuticalDoseForm: Tablet route: Oral use Names - ProductName Type * Stelbatolol 10mg Tablets Invented Name
identifier:
  system:
    v: http://example.org/identifiers/product
    l: product
  value:
    v: PROD-12345
combined pharmaceutical dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 10219000
    display:
      v: Tablet
route:
  coding:
    system:
      v: http://standardterms.edqm.eu
      l: standardterms.edqm.eu
    code:
      v: 20053000
    display:
      v: Oral use
name:
  product name:
    v: Stelbatolol 10mg Tablets
  type:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq
        l: cs-product-name-type-pq
      code:
        v: INV
      display:
        v: Invented Name

2h2h2h2h-2h2h-2h2h-2h2h-2h2h2h2h2h2h
type: Ingredient
id:
  v: ingredient-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq
    l: Ingredient-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-drug-pq-ex1 Profile: Ingredient - Drug Pq status: Active role: Active substance Codes - Reference * SubstanceDefinition: status = Active
status:
  v: active
role:
  coding:
    system:
      v: http://hl7.org/fhir/ingredient-role
      l: ingredient-role
    code:
      v: 100000072072
    display:
      v: Active
substance:
  code:
    reference:
      l: substancedefinition-component-substance-drug-pq-ex1
      reference:
        v: SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1

3h3h3h3h-3h3h-3h3h-3h3h-3h3h3h3h3h3h
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

4h4h4h4h-4h4h-4h4h-4h4h-4h4h4h4h4h4h
type: Medication
id:
  v: medication-batch-information-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq
    l: Medication-batch-information-drug-pq
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Medication medication-batch-information-drug-pq-ex1 Profile: Medication - Batch Information Drug PQ code: batch Medication Manufacturing Batch url manufacturingDate value: 2020-06 url batchQuantity value: 100100 tablets url batchUtilization value: Production url assignedManufacturer value: Organization AAA Molybdenum Products, Inc. closureSystemDescription: 100 cc HDPE Bottle 2 g desiccant url container Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Designation PQ: Maximum Extension - Batch Number of Vials PQ: 3 Extension - Batch Substance Batch PQ: Substance Extension - Packaging Date PQ: 2020-08 Extension - Packaging Site PQ: Organization AAA Molybdenum Products, Inc. Extension - Actual Yield PQ: 4.81 kg Extension - Actual Yield Unfiltered PQ: 4.91 kg Extension Target Fill Weight PQ: 30 g lotNumber: 33445
code:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
      l: Extension-medication-definition-pq
    value: Reference
      l: medicinalproductdefinition-drug-product-pq-ex1
      reference:
        v: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
batch:
  extension:
    extension:
      url:
        v: manufacturingDate
        l: manufacturingDate
      value: DateTime
        v: 2020-06
    extension:
      url:
        v: batchQuantity
        l: batchQuantity
      value: Quantity
    extension:
      url:
        v: batchUtilization
        l: batchUtilization
      value: CodeableConcept
    extension:
      url:
        v: assignedManufacturer
        l: assignedManufacturer
      value: Reference
        l: organization-drug-pq-ex1
    extension:
      extension:
        value: String
      url:
        v: container
        l: container
    url:
      v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
      l: medication-manufacturingBatch
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
      l: Extension-batch-release-date-pq
    value: DateTime
      v: 2019-09-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-designation-pq
      l: Extension-batch-designation-pq
    value: CodeableConcept
      text:
        v: Maximum
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq
      l: Extension-batch-number-of-vials-pq
    value: PositiveInt
      v: 3
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq
      l: Extension-batch-substance-batch-pq
    value: Reference
      l: substance-drug-pq-ex1
      reference:
        v: Substance/substance-drug-pq-ex1
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq
      l: Extension-packaging-date-pq
    value: DateTime
      v: 2020-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq
      l: Extension-packaging-site-pq
    value: Reference
      l: organization-drug-pq-ex1
      reference:
        v: Organization/organization-drug-pq-ex1
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
      l: Extension-actual-yield-pq
    value: Quantity
      value:
        v: 4.81
      unit:
        v: kg
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq
      l: Extension-actual-yield-unfiltered-pq
    value: Quantity
      value:
        v: 4.91
      unit:
        v: kg
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq
      l: Extension-target-fill-weight-pq
    value: Quantity
      value:
        v: 30
      unit:
        v: g
  lot number:
    v: 33445

5h5h5h5h-5h5h-5h5h-5h5h-5h5h5h5h5h5h
type: Substance
id:
  v: substance-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    l: Substance-drug-pq
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Substance substance-drug-pq-ex1 Profile: Substance - Drug PQ Medication Manufacturing Batch manufacturingDate: 2019-09-07 batchQuantity: 5 kg batchUtilization: Development assignedManufacturer: Organization AAA Molybdenum Products, Inc. Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: false Codes - Concept * Substance
extension:
  extension:
    url:
      v: manufacturingDate
      l: manufacturingDate
    value: DateTime
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
      l: batchQuantity
    value: Quantity
      value:
        v: 5
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
      l: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
      l: assignedManufacturer
    value: Reference
      l: organization-drug-pq-ex1
      reference:
        v: Organization/organization-drug-pq-ex1
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
    l: medication-manufacturingBatch
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
    l: Extension-batch-release-date-pq
  value: DateTime
    v: 2019-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
    l: Extension-batch-retest-date-pq
  value: DateTime
    v: 2022-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
    l: Extension-actual-yield-pq
  value: Quantity
    value:
      v: 4.8
    unit:
      v: kg
identifier:
  value:
    v: CAT1
instance:
  v: false
code:
  concept:
    text:
      v: Substance

6h6h6h6h-6h6h-6h6h-6h6h-6h6h6h6h6h6h
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
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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:
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        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:
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        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

7h7h7h7h-7h7h-7h7h-7h7h-7h7h7h7h7h7h
type: ActivityDefinition
id:
  v: activitydefinition-test-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    l: ActivityDefinition-test-drug-pq
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Metadata Title Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ. Generated using version 0.5.4 of the sample-content-ig Liquid templates
url:
  v: http://example-server.com/fhir/ActivityDefinition/activitydefinition-test-drug-pq-ex1
  l: activitydefinition-test-drug-pq-ex1
title:
  v: Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
status:
  v: active

8h8h8h8h-8h8h-8h8h-8h8h-8h8h8h8h8h8h
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

9h9h9h9h-9h9h-9h9h-9h9h-9h9h9h9h9h9h
type: DeviceDefinition
id:
  v: devicedefinition-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq
    l: DeviceDefinition-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DeviceDefinition devicedefinition-drug-pq-ex1 Profile: DeviceDefinition - Drug PQ DeviceNames - Name Type * Rotating Impeller with 1.5mm screen Registered name Properties - Type Value[x] * Maximum Speed 5000 RPM
device name:
  name:
    v: Rotating Impeller with 1.5mm screen
  type:
    v: registered-name
property:
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/device-property
        l: device-property
      code:
        v: Maximum Speed
      display:
        v: Maximum Speed
  value: Quantity
    value:
      v: 5000
    unit:
      v: RPM

0j0j0j0j-0j0j-0j0j-0j0j-0j0j0j0j0j0j
type: DiagnosticReport
id:
  v: diagnosticreport-analysis-drug-pq-stability-prod
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq
    l: DiagnosticReport-analysis-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod Profile: DiagnosticReport - Analysis Drug PQ Stability Study Report - 18 months When For 2020-12 Performer Organization AAA Molybdenum Products, Inc. Identifier https://eudract.europa.eu/example/identifier/ABC1234 Report Details Code Value Flags When For Test Components - Long-term 25C etc - Initial (XYZ) Final 2023-01-01 12:00:00+0000 The samples have been assessed for initial period; no shelf life determined.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
    l: workflow-triggeredBy
  value: Reference
    l: plandefinition-drug-pq-ex5-stability-study-protocol
    reference:
      v: PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq
    l: Extension-statistical-model-pq
  value: CodeableConcept
    text:
      v: information about statistical model utilized to interpret stability study results
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq
    l: Extension-container-orientation-pq
  value: CodeableConcept
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/container-orientation
        l: container-orientation
      code:
        v: horizontal
      display:
        v: horizontal
    text:
      v: Horizontal
identifier:
  system:
    v: https://eudract.europa.eu/example/identifier
    l: identifier
  value:
    v: ABC1234
status:
  v: final
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type
      l: pharmaceutical-report-type
    code:
      v: Stability Study Report - 18 months
    display:
      v: Stability Study Report - 18 months
effective: DateTime
  v: 2020-12
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq
      l: Extension-time-point-description-pq
    value: CodeableConcept
      text:
        v: Refrigerated delayed testing
performer:
  l: organization-drug-pq-ex1
  reference:
    v: Organization/organization-drug-pq-ex1
result:
  l: observation-test-result-longterm25c-initial-1
  reference:
    v: Observation/observation-test-result-longterm25c-initial-1
conclusion:
  v: The samples have been assessed for initial period; no shelf life determined.

1j1j1j1j-1j1j-1j1j-1j1j-1j1j1j1j1j1j
type: Procedure
id:
  v: procedure-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq
    l: Procedure-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Procedure procedure-drug-pq-ex1 Profile: Procedure - Drug PQ identifier: Run 1 status: Completed code: Media Challenge Run subject: Drug product
identifier:
  value:
    v: Run 1
status:
  v: completed
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: MediaChallengeRun
    display:
      v: Media Challenge Run
subject:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/alternate-reference
      l: alternate-reference
    value: Reference
      l: medicinalproductdefinition-drug-product-pq-ex1
      reference:
        v: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1
  display:
    v: Drug product

2j2j2j2j-2j2j-2j2j-2j2j-2j2j2j2j2j2j
type: Observation
id:
  v: observation-test-result-lt25c-i1-degradation-imp-total
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    l: Observation-test-result-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Observation observation-test-result-lt25c-i1-degradation-imp-total Profile: Observation - Test Result Drug PQ status: Final code: Degradation Products subject: Medication effective: 2023-01-01 12:00:00+0000 performer: Organization AAA Molybdenum Products, Inc. value: 0.801 % w/w (Details: UCUM code% = '%') Components - Code Value[x] * Impurity Total Degradation Impurities
status:
  v: final
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: DGP
    display:
      v: Degradation Products
  text:
    v: Degradation Products
subject:
  l: medication-batch-information-drug-pq-ex1
  reference:
    v: Medication/medication-batch-information-drug-pq-ex1
effective: DateTime
  v: 2023-01-01T12:00:00Z
performer:
  l: organization-drug-pq-ex1
  reference:
    v: Organization/organization-drug-pq-ex1
value: Quantity
  value:
    v: 0.801
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
    l: unitsofmeasure.org
  code:
    v: %
component:
  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: IMP
      display:
        v: Impurity
  value: CodeableConcept
    text:
      v: Total Degradation Impurities

3j3j3j3j-3j3j-3j3j-3j3j-3j3j3j3j3j3j
type: Organization
id:
  v: organization-drug-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
    l: Organization-drug-pq
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization organization-drug-pq-ex1 Profile: Organization - Drug PQ identifier: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html" title=""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."#xD;#xA;#xD;#xA;For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).">FDA Establishment Identifier/3003040516 active: true type: Drug Substance Manufacture name: AAA Molybdenum Products, Inc. Contacts - Address * 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
    l: 2.16.840.1.113883.4.82
  value:
    v: 3003040516
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
      l: pharmaceutical-organization-type
    code:
      v: drug-substance-manufacture
    display:
      v: Drug Substance Manufacture
name:
  v: AAA Molybdenum Products, Inc.
contact:
  address:
    line:
      v: 7233 W 116th Pl
    line:
      v: Ste C
    city:
      v: Broomfield
    state:
      v: Colorado
    postal code:
      v: 80020
    country:
      v: USA

v: 100100

v: tablets

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  l: Thesaurus.owl
code:
  v: C133990
display:
  v: Commercial

v: Production

v: Organization/organization-drug-pq-ex1

v: closureSystemDescription
l: closureSystemDescription

String
v: 100 cc HDPE Bottle 2 g desiccant

v: maximum

v: Maximum

v: C133991

v: Development

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

v: Delayed Start Code

v: Delayed Start Code