bundle-product-process-validation-pq-ex2-sub
type: Bundle
node role: treeRoot
id:
  v: bundle-product-process-validation-pq-ex2-sub
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq
type:
  v: collection

urn:…
type: PlanDefinition
text:
  status:
    v: extensions
  div: Generated Narrative: PlanDefinition Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f" url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f title: DP PROCESS VALIDATION type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#process-validation "Process Validation") status: active subject: See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390 description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies... action Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale') Extension - Process Parameters PQ url parameter value: Mix speed (Process Parameter Codes#SPEED) url value value: 1500 rpm prefix: 1 title: Step 1 Yield description: Description of this step code: Particle Size Reduction (Manufacturing Step Codes#particleSizeReduction) participant typeReference: : Starting material role: Starting Material (Manufacturing Participant Role Codes#StartingMaterial) participant typeReference: : Intermediate material role: Intermediate Material (Manufacturing Participant Role Codes#IntermediateMaterial) participant typeReference: : Resulting material role: Resulting Material (Manufacturing Participant Role Codes#ResultingMaterial) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 action title: Step 1 In-Process Control Data code: Step 1 In-Process Control Data (Manufacturing Step Codes#Step1In-ProcessControlData) Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72 * Test () http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72 action title: Step 1 DS Releas…
url:
  v: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
title:
  v: DP PROCESS VALIDATION
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type
    code:
      v: process-validation
    display:
      v: Process Validation
status:
  v: active
subject: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
description:
  v: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...
action:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale
      code:
        v: PROD
      display:
        v: Production Scale
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq
    extension:
      url:
        v: parameter
      value: CodeableConcept
    extension:
      url:
        v: value
      value: Quantity
  prefix:
    v: 1
  title:
    v: Step 1 Yield
  description:
    v: Description of this step
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      code:
        v: particleSizeReduction
      display:
        v: Particle Size Reduction
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Starting material
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Intermediate material
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Resulting material
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
      link: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
action:
  title:
    v: Step 1 In-Process Control Data
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      code:
        v: Step1In-ProcessControlData
      display:
        v: Step 1 In-Process Control Data
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
      link: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
      link: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
action:
  title:
    v: Step 1 DS Release Testing Results
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      code:
        v: Step1DSReleaseTestingResults
      display:
        v: Step 1 DS Release Testing Results
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
      link: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
      link: http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
      link: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
action:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq
    value: Coding
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale
      code:
        v: PROD
      display:
        v: Production Scale
  prefix:
    v: 2
  title:
    v: Step 2 Yield
  description:
    v: Description of this step
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/manufacturing-step
      code:
        v: drying
      display:
        v: Drying
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Starting material
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Intermediate material
  participant:
    type reference:
      extension:
        value: Reference
      display:
        v: Resulting material
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
      link: http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72

urn:…
type: DiagnosticReport
id:
  v: processValidationReport
text:
  status:
    v: extensions
  div: Generated Narrative: DiagnosticReport Resource DiagnosticReport "processValidationReport" Triggered by: See on this page: PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f status: final code: Process Validation Report (Pharmaceutical Report Type Codes#Process Validation Report) effective: 2020-12 result: See on this page: Observation/9c56948c-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-2b39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948a-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56958c-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56968a-2b39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56978a-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948c-2a39-6609-2c01-4d197ea57a33 See on this page: Observation/9c56948c-2a49-6609-2c01-4d197ea57a33 See on this page: Observation/9c56948c-2a39-6609-2c01-4d197eb57a33 See on this page: Observation/9c56958c-2a39-6609-2c01-4d197ea57a33 See on this page: Observation/9c56968c-2a49-6609-2c01-4d197ea57a33 See on this page: Observation/9c56978c-2a39-6609-2c01-4d197eb57a33 See on this page: Observation/9c56948d-2a39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948c-2b39-6609-1c01-4d197ea57a33 See on this page: Observation/9c56948b-2a39-6609-1c01-4d197ea57a33 conclusion: The samples have been assessed and the conclusion is...
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
status:
  v: final
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type
    code:
      v: Process Validation Report
    display:
      v: Process Validation Report
effective:
  v: 2020-12
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948c-2a39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948a-2b39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948a-2a39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56958c-2a39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56968a-2b39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56978a-2a39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948c-2a39-6609-2c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948c-2a49-6609-2c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948c-2a39-6609-2c01-4d197eb57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56958c-2a39-6609-2c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56968c-2a49-6609-2c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56978c-2a39-6609-2c01-4d197eb57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948d-2a39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948c-2b39-6609-1c01-4d197ea57a33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c56948b-2a39-6609-1c01-4d197ea57a33
conclusion:
  v: The samples have been assessed and the conclusion is...

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc07b5d5-9fe1-92c2-2d06-57cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72 title: Appearance status: active code: Appearance (Example Local Codes - Drug#Appearance) method: Visual inspection () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
title:
  v: Appearance
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Appearance
    display:
      v: Appearance
  text:
    v: Appearance
method:
  text:
    v: Visual inspection
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: White to off-white, to red, to orange, to brown solid

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "3b1e878e-4bc9-8864-862f-e28b21233e8d" url: http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d title: ID by HPLC status: active code: ID by HPLC (Example Local Codes - Drug#IDT "Identification") method: ID by UHPLC () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
title:
  v: ID by HPLC
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: ID by HPLC
method:
  text:
    v: ID by UHPLC
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Conforms to standard

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" url: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e title: Assay by HPLC (as is) (w/w%) status: active code: Assay by HPLC (as is) (w/w%) (Example Local Codes - Drug#ASSAY "Assay") method: Assay by UHPLC () QualifiedValues - Range * 95-101 %
url:
  v: http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
title:
  v: Assay by HPLC (as is) (w/w%)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay by HPLC (as is) (w/w%)
method:
  text:
    v: Assay by UHPLC
qualified value:
  range:
    low:
      value:
        v: 95
      unit:
        v: %
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    high:
      value:
        v: 101
      unit:
        v: %
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 title: Yield (%) status: active code: Yield (%) (Example Local Codes - Drug#Yield (%))
url:
  v: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
title:
  v: Yield (%)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "fd17b5d7-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72 title: Yield (%) status: active code: Yield (%) (Example Local Codes - Drug#Yield (%))
url:
  v: http://example-server.com/fhir/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
title:
  v: Yield (%)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b5d6-9fe1-91c2-2d16-57cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72 title: Residual Water Content (w/w%) status: active code: Residual Water Content (w/w%) (Example Local Codes - Drug#ResidualWaterContent) QualifiedValues - Extension Range * ?-7.15
url:
  v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
title:
  v: Residual Water Content (w/w%)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ResidualWaterContent
    display:
      v: Residual Water Content (w/w%)
  text:
    v: Residual Water Content (w/w%)
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
    value: CodeableConcept
      text:
        v: Non-critical
  range:
    high:
      value:
        v: 7.15
      unit:
        v: %
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "fc27b5d6-9ff1-91c2-2d16-57cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72 title: Reaction conversion: residual starting material 1 by HPLC (Step Aa) (LC area %) status: active code: Reaction conversion: Residual Starting Material 1 by HPLC (Example Local Codes - Drug#Reaction conversion: Residual Starting Material 1 by HPLC) QualifiedValues - Extension Range * ?-23
url:
  v: http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9ff1-91c2-2d16-57cb5b295e72
title:
  v: Reaction conversion: residual starting material 1 by HPLC (Step Aa) (LC area %)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Reaction conversion: Residual Starting Material 1 by HPLC
    display:
      v: Reaction conversion: Residual Starting Material 1 by HPLC
  text:
    v: Reaction conversion: Residual Starting Material 1 by HPLC
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-criticality-pq
    value: CodeableConcept
      text:
        v: Critical
  range:
    high:
      value:
        v: 23
      unit:
        v: %
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948c-2a39-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72 status: final code: Appearance (Example Local Codes - Drug#Appearance) subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Off-white solid
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Appearance
    display:
      v: Appearance
  text:
    v: Appearance
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Off-white solid

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948c-2a49-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72 status: final code: Appearance (Example Local Codes - Drug#Appearance) subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Off-white solid
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Appearance
    display:
      v: Appearance
  text:
    v: Appearance
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Off-white solid

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948c-2a39-6609-2c01-4d197eb57a33" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72 status: final code: Appearance (Example Local Codes - Drug#Appearance) subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Off-white solid
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc07b5d5-9fe1-92c2-2d06-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Appearance
    display:
      v: Appearance
  text:
    v: Appearance
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Off-white solid

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56958c-2a39-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d status: final code: ID by HPLC (Example Local Codes - Drug#IDT "Identification") subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: ID by HPLC
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Conforms

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56968c-2a49-6609-2c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d status: final code: ID by HPLC (Example Local Codes - Drug#IDT "Identification") subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: ID by HPLC
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Conforms

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56978c-2a39-6609-2c01-4d197eb57a33" instantiates: See on this page: ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d status: final code: ID by HPLC (Example Local Codes - Drug#IDT "Identification") subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not conform
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/3b1e878e-4bc9-8864-862f-e28b21233e8d
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: ID by HPLC
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value:
  v: Does not conform

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948c-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 75 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 75
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948a-2b39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 77 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 77
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948a-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 76 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 76
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948d-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178763-81c5-5656-9754-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 85 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178763-81c5-5656-9754-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 85
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948c-2b39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178764-81d5-5656-9764-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 87 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d5-5656-9764-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 87
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56948b-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72 status: final code: Yield (%) (Example Local Codes - Drug#Yield (%)) subject: See on this page: Substance/fc178764-81d6-6656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 86 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fd17b5d7-9fe1-91c2-2d06-47cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Yield (%)
    display:
      v: Yield (%)
  text:
    v: Yield (%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d6-6656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 86
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56958c-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72 status: final code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)") subject: See on this page: Substance/fc178763-81c5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.9 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ResidualWaterContent
    display:
      v: Residual Water Content (w/w%)
  text:
    v: ResidualWaterContent (w/w%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178763-81c5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 6.9
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56968a-2b39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72 status: final code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)") subject: See on this page: Substance/fc178764-81d5-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 7.0 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ResidualWaterContent
    display:
      v: Residual Water Content (w/w%)
  text:
    v: ResidualWaterContent (w/w%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d5-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 7.0
  unit:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c56978a-2a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72 status: final code: ResidualWaterContent (w/w%) (Example Local Codes - Drug#ResidualWaterContent "Residual Water Content (w/w%)") subject: See on this page: Substance/fc178764-81d6-5656-9744-13c7ad1e595b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 6.8 %
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-57cb5b295e72
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ResidualWaterContent
    display:
      v: Residual Water Content (w/w%)
  text:
    v: ResidualWaterContent (w/w%)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178764-81d6-5656-9744-13c7ad1e595b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 6.8
  unit:
    v: %

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "23dbbd32-2962-9fc3-40b1-67e864f21cd2" identifier: urn:oid:2.16.840.1.113883.4.82/3003040516 active: true type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#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
  value:
    v: 3003040516
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/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

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release) name: Testing Lab
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 3007270600
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
    code:
      v: analytical-testing-release
    display:
      v: Analytical Testing - Release
name:
  v: Testing Lab

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" Profile: SubstanceDefinition - Component Substance Drug PQ manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Names - Name * Stelbatolol
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
name:
  name:
    v: Stelbatolol

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * Stelbatosubstance
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
name:
  name:
    v: Stelbatosubstance

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-01 url batchQuantity value: 8.1 kg identifier: Start1Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-01
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 8.1
      unit:
        v: kg
identifier:
  value:
    v: Start1Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81d5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-01 url batchQuantity value: 8.2 kg identifier: Start2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-01
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 8.2
      unit:
        v: kg
identifier:
  value:
    v: Start2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81d5-5656-9744-23c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-01 url batchQuantity value: 8.3 kg identifier: Start3Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-01
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 8.3
      unit:
        v: kg
identifier:
  value:
    v: Start3Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154" Names - Name * Resultothane
name:
  name:
    v: Resultothane

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * Processohol
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
name:
  name:
    v: Processohol

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178763-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 9.1 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81c5-5656-9744-13c7ad1e595b identifier: Intermed1Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 9.1
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81c5-5656-9744-13c7ad1e595b
identifier:
  value:
    v: Intermed1Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178764-81d5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 9.2 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-13c7ad1e595b identifier: Intermed2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 9.2
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81d5-5656-9744-13c7ad1e595b
identifier:
  value:
    v: Intermed2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178764-81d6-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 9.3 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-23c7ad1e595b identifier: Intermed3Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 9.3
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81d5-5656-9744-23c7ad1e595b
identifier:
  value:
    v: Intermed3Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-8cb8-428e-83f7-8a205f821153" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * Stelbatosubstance2
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
name:
  name:
    v: Stelbatosubstance2

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81c5-5656-9744-13c7ad2e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-02 url batchQuantity value: 7.1 kg identifier: Start1Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-02
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 7.1
      unit:
        v: kg
identifier:
  value:
    v: Start1Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81d5-5656-9744-13c7ad1e596b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-02 url batchQuantity value: 7.2 kg identifier: Start2Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-02
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 7.2
      unit:
        v: kg
identifier:
  value:
    v: Start2Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178762-81d5-5656-9744-23c7ad1e597b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-02 url batchQuantity value: 7.3 kg identifier: Start3Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-02
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 7.3
      unit:
        v: kg
identifier:
  value:
    v: Start3Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-8cb8-428e-83f7-8a205f821153

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-84f7-8a205f821155" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * ProcessoholStep2
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2
name:
  name:
    v: ProcessoholStep2

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178763-81c5-5656-9754-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 10.1 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81c5-5656-9744-13c7ad2e595b identifier: Intermed1Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 10.1
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81c5-5656-9744-13c7ad2e595b
identifier:
  value:
    v: Intermed1Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178764-81d5-5656-9764-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 10.2 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-13c7ad1e596b identifier: Intermed2Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 10.2
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81d5-5656-9744-13c7ad1e596b
identifier:
  value:
    v: Intermed2Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc178764-81d6-6656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url batchQuantity value: 10.3 kg Extension - Batch Derived From PQ: See on this page: Substance/fc178762-81d5-5656-9744-23c7ad1e597b identifier: Intermed3Step2Amgen instance: true Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 10.3
      unit:
        v: kg
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-derived-from-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc178762-81d5-5656-9744-23c7ad1e597b
identifier:
  value:
    v: Intermed3Step2Amgen
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-84f7-8a205f821155

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-8cb8-428e-83f7-8a205f821154" Names - Name * ResultothaneStep2
name:
  name:
    v: ResultothaneStep2

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" Profile: Organization - Drug PQ identifier: urn:oid:2.16.840.1.113883.4.82/3003040516 active: true type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#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
  value:
    v: 3003040516
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/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

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5.1 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: SUB1Amgen, SUB1SiteA instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 5.1
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
  value:
    v: 2019-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
  value:
    v: 2022-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
  value: Quantity
    value:
      v: 4.8
    unit:
      v: kg
identifier:
  value:
    v: SUB1Amgen
identifier:
  value:
    v: SUB1SiteA
  assigner:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

urn:…
type: Substance
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5.2 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: SUB2Amgen, SUB2SiteA instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 5.2
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
  value:
    v: 2019-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
  value:
    v: 2022-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
  value: Quantity
    value:
      v: 4.8
    unit:
      v: kg
identifier:
  value:
    v: SUB2Amgen
identifier:
  value:
    v: SUB2SiteA
  assigner:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

urn:…
type: Substance
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5.3 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: SUB3Amgen, SUB3SiteA instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 5.3
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
  value:
    v: 2019-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
  value:
    v: 2022-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
  value: Quantity
    value:
      v: 4.8
    unit:
      v: kg
identifier:
  value:
    v: SUB3Amgen
identifier:
  value:
    v: SUB3SiteA
  assigner:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

system:
  v: http://terminology.hl7.org/CodeSystem/process-parameter
code:
  v: SPEED
display:
  v: Mix speed

v: 1500

v: rpm

v: StartingMaterial

v: Starting Material

v: IntermediateMaterial

v: Intermediate Material

v: ResultingMaterial

v: Resulting Material

v: StartingMaterial

v: Starting Material

v: IntermediateMaterial

v: Intermediate Material

v: ResultingMaterial

v: Resulting Material

v: Non-critical

v: Non-critical

v: critical

v: Critical

v: C133991

v: Development

v: C133991

v: Development

v: C133991

v: Development