bundle-drug-product-specification-pq-ex1
type: Bundle
node role: treeRoot
id:
  v: bundle-drug-product-specification-pq-ex1
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq
type:
  v: collection

urn:…
type: PlanDefinition
id:
  v: plandefinition-drug-pq-ex3-drug-specification
text:
  status:
    v: generated
  div: Generated Narrative: PlanDefinition Resource PlanDefinition "plandefinition-drug-pq-ex3-drug-specification" url: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a title: SPECIFICATION(S) FOR DRUG PRODUCT status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Narrative description of specifications action title: Specification(s) for Drug Product code: Overall set of actions () action title: Release code: Timing Group () timing: Code: Release time action action action action action action action action action title: End of shelf life code: Timing Group () timing: Code: At end of shelf life action action action action action action action action
url:
  v: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
title:
  v: SPECIFICATION(S) FOR DRUG PRODUCT
status:
  v: active
subject: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
description:
  v: Narrative description of specifications
action:
  title:
    v: Specification(s) for Drug Product
  code:
    text:
      v: Overall set of actions
  action:
    title:
      v: Release
    code:
      text:
        v: Timing Group
    timing: Timing
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
        link: http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
        link: http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
        link: http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
        link: http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
        link: http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
        link: http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
        link: http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
        link: http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
  action:
    title:
      v: End of shelf life
    code:
      text:
        v: Timing Group
    timing: Timing
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
        link: http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
        link: http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
        link: http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
        link: http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
        link: http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
        link: http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
        link: http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
    action:
      definition:
        v: http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
        link: http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "77e7020a-270c-6bed-2e55-28e9e942546c" url: http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c title: Description status: active code: Description (Example Local Codes - Drug#DESC) method: Visual inspection () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
title:
  v: Description
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DESC
    display:
      v: Description
  text:
    v: Description
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: An orange film-coated tablet, debossed with 175 on one side

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "d24ce3cd-213d-4935-97cf-8e2dd03721ec" url: http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec title: Description status: active code: Description (Example Local Codes - Drug#DESC) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
title:
  v: Description
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DESC
    display:
      v: Description
  text:
    v: Description
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12" url: http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12 title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) method: ID by UHPLC () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
title:
  v: Identification
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: Identification
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: Consistent with the retention time and UV spectrum of the reference standard

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "f77ba972-5ef8-a178-9a5f-fe7f54da7499" url: http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499 title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
title:
  v: Identification
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: Identification
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "c0f05343-5b98-6073-1a0f-873aaf4f59bc" url: http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by UHPLC () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
title:
  v: Assay
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
method:
  text:
    v: Assay by UHPLC
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: 95% to 105% of label claim

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f" url: http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
title:
  v: Assay
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
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "a3d4d23a-800a-684a-6a47-fcfe44e06041" url: http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041 title: Degradation Products status: active code: Degradation Products (Example Local Codes - Drug#DGP) method: Degradation products by UHPLC () qualifiedValue appliesTo: Impurity 1 () range: ?-0.2 qualifiedValue appliesTo: Impurity 2 () range: ?-0.3 qualifiedValue appliesTo: Impurity 3 () range: ?-0.3 qualifiedValue appliesTo: Individual unspecified degradation products () range: ?-0.2 qualifiedValue appliesTo: Total degradation products () range: ?-1.4 Components - Code * Impurity (Example Local Codes - Drug#IMP)
url:
  v: http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
title:
  v: Degradation Products
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DGP
    display:
      v: Degradation Products
method:
  text:
    v: Degradation products by UHPLC
qualified value:
  applies to:
    text:
      v: Impurity 1
  range:
    high:
      value:
        v: 0.2
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 2
  range:
    high:
      value:
        v: 0.3
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 3
  range:
    high:
      value:
        v: 0.3
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Individual unspecified degradation products
  range:
    high:
      value:
        v: 0.2
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Total degradation products
  range:
    high:
      value:
        v: 1.4
      unit:
        v: % w/w
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: IMP
      display:
        v: Impurity

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef72eeb7-211a-3c16-8460-8725ca43584f" url: http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f title: Degradation Products status: active code: Degradation Products (Example Local Codes - Drug#DGP) qualifiedValue appliesTo: Impurity 1 () range: ?-0.8 qualifiedValue appliesTo: Impurity 2 () range: ?-0.4 qualifiedValue appliesTo: Impurity 3 () range: ?-0.4 qualifiedValue appliesTo: Individual unspecified degradation products () range: ?-2.3 qualifiedValue appliesTo: Total degradation products () range: ?-2.3 Components - Code * Impurity (Example Local Codes - Drug#IMP)
url:
  v: http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
title:
  v: Degradation Products
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DGP
    display:
      v: Degradation Products
qualified value:
  applies to:
    text:
      v: Impurity 1
  range:
    high:
      value:
        v: 0.8
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 2
  range:
    high:
      value:
        v: 0.4
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 3
  range:
    high:
      value:
        v: 0.4
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Individual unspecified degradation products
  range:
    high:
      value:
        v: 2.3
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Total degradation products
  range:
    high:
      value:
        v: 2.3
      unit:
        v: % w/w
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: IMP
      display:
        v: Impurity

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "bb11322b-9470-4f13-91b5-c8a5253380eb" url: http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb title: Dissolution status: active code: Dissolution (Example Local Codes - Drug#Dissolution) method: Apparatus 2 (paddles), UV measurement () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
title:
  v: Dissolution
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Dissolution
    display:
      v: Dissolution
  text:
    v: Dissolution
method:
  text:
    v: Apparatus 2 (paddles), UV measurement
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea" url: http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea title: Dissolution status: active code: Dissolution (Example Local Codes - Drug#Dissolution) method: Apparatus 2 (paddles), UV measurement () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
title:
  v: Dissolution
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Dissolution
    display:
      v: Dissolution
  text:
    v: Dissolution
method:
  text:
    v: Apparatus 2 (paddles), UV measurement
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1" url: http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP <921> () QualifiedValues - Range * ?-1.0
url:
  v: http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
title:
  v: Water Content
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
  text:
    v: Water Content
method:
  text:
    v: USP <921>
qualified value:
  range:
    high:
      value:
        v: 1.0
      unit:
        v: % w/w

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "91391017-774b-5c77-93fa-642534278851" url: http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP <921> () QualifiedValues - Range * ?-2.0
url:
  v: http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
title:
  v: Water Content
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
  text:
    v: Water Content
method:
  text:
    v: USP <921>
qualified value:
  range:
    high:
      value:
        v: 2.0
      unit:
        v: % w/w

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "64972eb3-99ee-7eae-2f63-733e5ae84f71" url: http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71 title: Microbiological status: active code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) method: Ph Eur () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
title:
  v: Microbiological
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
  text:
    v: Microbiological Quality
method:
  text:
    v: Ph Eur
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Shall comply with the requirements of the Ph Eur

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "e582e504-36ec-3b50-4043-51bf1147124e" url: http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e title: Microbiological status: active code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) method: Ph Eur () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
title:
  v: Microbiological
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
  text:
    v: Microbiological Quality
method:
  text:
    v: Ph Eur
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "e7e2fe59-5433-5cc0-84b1-d5f30032790c" url: http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c title: Uniformity of dosage status: active code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) method: Weight variation () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
title:
  v: Uniformity of dosage
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: uniformity of dosage units (by weight)
  text:
    v: uniformity of dosage units (by weight)
method:
  text:
    v: Weight variation
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Shall comply with the requirements of the harmonised USP/JP/Ph Eur

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "43dbc2a3-00c4-6f79-6b11-63768b412aa3" url: http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3 title: Uniformity of dosage status: active code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
title:
  v: Uniformity of dosage
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: uniformity of dosage units (by weight)
  text:
    v: uniformity of dosage units (by weight)
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: As for release

urn:…
type: MedicinalProductDefinition
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" description: Textual description of the product combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000) route: Oral use (standardterms.edqm.eu#20053000) name productName: Stelbat Tablets, 20mg type: Proprietary (Product Name Type - example#Proprietary) Parts - Part Type * 20mg Strength part (Product Name Part Type#StrengthPart)
description:
  v: Textual description of the product
combined pharmaceutical dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10225000
    display:
      v: Gastro-resistant tablet
route:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 20053000
    display:
      v: Oral use
name:
  product name:
    v: Stelbat Tablets, 20mg
  type:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example
      code:
        v: Proprietary
      display:
        v: Proprietary
  part:
    part:
      v: 20mg

urn:…
type: Ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" status: active for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 role: Active (Ingredient Role#100000072072) substance Codes - Reference * See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152
status:
  v: active
for:
  link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role:
  coding:
    system:
      v: http://hl7.org/fhir/ingredient-role
    code:
      v: 100000072072
    display:
      v: Active
substance:
  code:
    reference:
      link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d Names - Name * Stelbatolol
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
name:
  name:
    v: Stelbatolol

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" 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

v: Release time

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: At end of shelf life

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: Test

v: StrengthPart

v: Strength part