ControlMaterialsBundle
type: Bundle
node role: treeRoot
id:
  v: ControlMaterialsBundle
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23
identifier:
  system:
    v: urn:ietf:rfc:3986
type:
  v: document
timestamp:
  v: 2023-12-05T01:34:39.503Z

urn:…
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23
text:
  status:
    v: generated
  div: Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd Profile: eCTD Substance Control of Materials identifier: materials1 status: Final type: m3.2.s.2.3 control of materials date: 2023-12-05 01:34:39+0000 author: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 title: Control of Materials Example
identifier:
  value:
    v: materials1
status:
  v: final
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    code:
      v: ich_3.2.s.2.3
    display:
      v: m3.2.s.2.3 control of materials
date:
  v: 2023-12-05T01:34:39.502Z
title:
  v: Control of Materials Example
section:
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
      code:
        v: ich_3.2.s.3.1
      display:
        v: m3.2.s.3.1 elucidation of structure and other characteristics
section:
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
      code:
        v: ich_3.2.s.3.1
      display:
        v: m3.2.s.3.1 elucidation of structure and other characteristics
section:
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
      code:
        v: ich_3.2.s.3.1
      display:
        v: m3.2.s.3.1 elucidation of structure and other characteristics

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a Profile: Drug Substance Handle identifier: salicylate classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * R16CO5Y76E name name: ACETYLSALICYLIC ACID type: Generic Name name name: ASPIRIN type: GSRS Preferred Term preferred: true
identifier:
  value:
    v: salicylate
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: R16CO5Y76E
name:
  name:
    v: ACETYLSALICYLIC ACID
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C97054
      display:
        v: Generic Name
name:
  name:
    v: ASPIRIN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 783452221
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134004
      display:
        v: FEI
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 6913973
name:
  v: Manufacturing Site (J. Jones Research)
contact:
  address:
    type:
      v: postal
    text:
      v: Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
    line:
      v: 444 Grant Street
    city:
      v: Bedford
    state:
      v: NY
    postal code:
      v: 15600
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5 Profile: Basic Organization identifier: DUNS/143265222, FEI/6981397 name: Vidinaid Contacts - Address * Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134004
      display:
        v: FEI
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 6981397
name:
  v: Vidinaid
contact:
  address:
    type:
      v: postal
    text:
      v: Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
    line:
      v: 100 Stillwater Avenue
    line:
      v: Building #2
    city:
      v: Bangor
    state:
      v: ME
    postal code:
      v: 04401
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 Profile: Basic Organization identifier: DUNS/173265332 name: Mega Chem Supply Contacts - Address * Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 173265332
name:
  v: Mega Chem Supply
contact:
  address:
    type:
      v: postal
    text:
      v: Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
    line:
      v: 350 W Main Street
    city:
      v: Rochester
    state:
      v: NY
    postal code:
      v: 14608
    country:
      v: USA

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703 Profile: Excipient Drug Substance identifier: carrageenan classification: Structurally Diverse Substance grade: Company Standard manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * 5C69YCD2YJ Names - Name Type Preferred * Carrageenan GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant palmaria palmata whole United States of America
identifier:
  value:
    v: carrageenan
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C103206
    display:
      v: Structurally Diverse Substance
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134009
    display:
      v: Company Standard
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 5C69YCD2YJ
name:
  name:
    v: Carrageenan
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C14258
      display:
        v: Plant
  genus:
    text:
      v: palmaria
  species:
    text:
      v: palmata
  part:
    text:
      v: whole
  country of origin:
    coding:
      system:
        v: urn:iso:std:iso:3166
      code:
        v: USA
      display:
        v: United States of America

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a Profile: Excipient Drug Substance identifier: Citric acid classification: Chemical grade: Company Standard manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * XF417D3PSL Names - Name Type Preferred * ANHYDROUS CITRIC ACID GSRS Preferred Term true SourceMaterials - Type * Chemical
identifier:
  value:
    v: Citric acid
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134009
    display:
      v: Company Standard
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: XF417D3PSL
name:
  name:
    v: ANHYDROUS CITRIC ACID
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd Profile: Excipient Drug Substance identifier: water classification: Chemical grade: BP manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical
identifier:
  value:
    v: water
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C176793
    display:
      v: BP
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 059QF0KO0R
name:
  name:
    v: WATER
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: PlanDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
text:
  status:
    v: extensions
  div: Id: ab241f8c-d21e-4382-a70a-52190dbdf07e Version: 1.0 RawCitricacid Title: Raw Material (Carrageenan) Specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703 Date: 2023-11-28 Actions: Single Stage Identification: Then: Identification A: Identification B: Identification C: Identification D: Single Stage Microbial Limits: Then: Total Bacterial Count: Salmonella: Escherichia Coli: Single Stage Elemental Impurities: Then: Cadmium (Cd): Mercury (Hg): Arsenic (As): Lead (Pb): Single Stage Residual Solvents: Single Stage Impurity: Insoluble Matter: Single Stage Solubility in H2O:
extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48660
      display:
        v: Not Applicable
identifier:
  value:
    v: RawCitricacid
version:
  v: 1.0
title:
  v: Raw Material (Carrageenan) Specification Example
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C133931
    display:
      v: Raw Materials/Excipients/Intermediates/Reagents
status:
  v: active
subject: Reference
date:
  v: 2023-11-28
goal:
  description:
    text:
      v: Viscous upon cooling
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Viscous upon cooling
goal:
  description:
    text:
      v: Kappa, iota or lambda
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Kappa, iota or Lambda
goal:
  description:
    text:
      v: Blue, stringy precipitate forms
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Blue stringy precipitate forms
goal:
  description:
    text:
      v: FTIR matches standard
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: FTIR matches standard
goal:
  description:
    text:
      v: max 200 cfu/g
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: Quantity
      value:
        v: 200
      comparator:
        v: <=
      unit:
        v: colony forming unit
      system:
        v: http://unitsofmeasure.org
      code:
        v: [CFU]
goal:
  description:
    text:
      v: Negative
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Negative
goal:
  description:
    text:
      v: Negative
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029

urn:…
type: PlanDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
text:
  status:
    v: extensions
  div: Id: a2cba634-a481-4b07-9bd4-62c7ada31e1b Version: 1.0 CitricAcidSpecification Title: Citric acid specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a Date: 2023-12-01 Actions: Single Stage Appearance: Single Stage Identification: Single Stage [pH]: Single Stage Residue on Ignition:
extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48660
      display:
        v: Not Applicable
identifier:
  value:
    v: CitricAcidSpecification
version:
  v: 1.0
title:
  v: Citric acid specification Example
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C133931
    display:
      v: Raw Materials/Excipients/Intermediates/Reagents
status:
  v: active
subject: Reference
date:
  v: 2023-12-01
goal:
  description:
    text:
      v: White Solid
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: White solid
goal:
  description:
    text:
      v: IR spectrum conforms to reference standard
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: IR spectrum conforms to reference standard
goal:
  description:
    text:
      v: pH 3.4-4.3
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    modifier extension:
      extension:
        value: Quantity
      extension:
        value: Quantity
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range
goal:
  description:
    text:
      v: residue <= 0.21%
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: Quantity
      value:
        v: 0.21
      comparator:
        v: <=
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
action:
  prefix:
    v: Single Stage
  title:
    v: Appearance
  code:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96103
      display:
        v: Proprietary
    text:
      v: Visual
  reason:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
      value: positiveInt
        v: 1
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C205026
      display:
        v: Organoleptic
  reason:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
      value: positiveInt
        v: 2
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C138990
      display:
        v: Description/Appearance
  documentation:
    type:
      v: documentation
    label:
      v: EX-TEST-101
action:
  prefix:
    v: Single Stage

urn:…
type: PlanDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
text:
  status:
    v: extensions
  div: Id: 5819b223-d3d2-419f-b617-b3a9a3625b89 Version: 1.0 WaterSpecification Title: Water Specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd Date: 2023-12-01 Actions: Single Stage Color degree: Single Stage Turbidity: Single Stage Smell and taste: Single Stage Total hardness:
extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48660
      display:
        v: Not Applicable
identifier:
  value:
    v: WaterSpecification
version:
  v: 1.0
title:
  v: Water Specification Example
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C133931
    display:
      v: Raw Materials/Excipients/Intermediates/Reagents
status:
  v: active
subject: Reference
date:
  v: 2023-12-01
goal:
  description:
    text:
      v: <=12 deg
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  target:
    detail: Quantity
      value:
        v: 12
      comparator:
        v: <=
      unit:
        v: degree
      system:
        v: http://unitsofmeasure.org
      code:
        v: deg
goal:
  description:
    text:
      v: Conforms to reference standard
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  target:
    detail: string
      v: Conforms to reference standard
goal:
  description:
    text:
      v: Odorless
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  target:
    detail: string
      v: Odorless
goal:
  description:
    text:
      v: <= 395mg/L
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  target:
    detail: Quantity
      value:
        v: 395
      comparator:
        v: <=
      unit:
        v: milligram
      system:
        v: http://unitsofmeasure.org
      code:
        v: mg
action:
  prefix:
    v: Single Stage
  title:
    v: Color degree
  code:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96103
      display:
        v: Proprietary
    text:
      v: Colorimetry
  reason:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
      value: positiveInt
        v: 1
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C205026
      display:
        v: Organoleptic
  reason:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
      value: positiveInt
        v: 2
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134262
      display:
        v: Color of Solution
  documentation:
    type:
      v: documentation
    label:
      v: EX-TEST-201
action:
  prefix:
    v: Single Stage
  title:
    v: Turbidity
  code:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96103
      display:
        v: Proprietary
    text:
      v: Spectrophotometer
  reason:
    extension:
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
      value: positiveInt
        v: 1
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C74723
      display:
        v: Turbidity
  documentation:
    type:
      v: documentation

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519 Profile: Basic Organization identifier: DUNS/143265625 name: J. Jones Research Contacts - Address * J. Jones Research, 123 Broad Way, New York, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265625
name:
  v: J. Jones Research
contact:
  address:
    type:
      v: postal
    text:
      v: J. Jones Research, 123 Broad Way, New York, NY, United States
    line:
      v: 123 Broad Way
    city:
      v: New York
    state:
      v: NY
    postal code:
      v: 00062
    country:
      v: USA

v: Release

coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C134030
  display:
    v: Stability

detail: string
  v: Negative

description:
  text:
    v: As Reported
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: string
    v: As Reported

description:
  text:
    v: As Reported
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: string
    v: As Reported

description:
  text:
    v: <= 3 ppm
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 3
    comparator:
      v: <=
    unit:
      v: part per million
    system:
      v: http://unitsofmeasure.org
    code:
      v: [ppm]

description:
  text:
    v: <= 10 ppm
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 10
    comparator:
      v: <=
    unit:
      v: part per million
    system:
      v: http://unitsofmeasure.org
    code:
      v: [ppm]

description:
  text:
    v: As Reported
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: string
    v: As Reported

description:
  text:
    v: <= 2.0%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 2
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: <30ml H2O @ 25C
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 30
    comparator:
      v: <=
    unit:
      v: milliliter
    system:
      v: http://unitsofmeasure.org
    code:
      v: mL
target:
  detail: Quantity
    value:
      v: 25
    comparator:
      v: <=
    unit:
      v: degree Celsius
    system:
      v: http://unitsofmeasure.org
    code:
      v: Cel

prefix:
  v: Single Stage
title:
  v: Identification
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C138993
    display:
      v: Identification
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-001
action:
  title:
    v: Identification A
action:
  title:
    v: Identification B
action:
  title:
    v: Identification C
action:
  title:
    v: Identification D

prefix:
  v: Single Stage
title:
  v: Microbial Limits
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134256
    display:
      v: Microbial Limits
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-002
action:
  title:
    v: Total Bacterial Count
action:
  title:
    v: Salmonella
action:
  title:
    v: Escherichia Coli

prefix:
  v: Single Stage
title:
  v: Elemental Impurities
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: UV
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205014
    display:
      v: Elemental Impurity
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-003
action:
  title:
    v: Cadmium (Cd)
action:
  title:
    v: Mercury (Hg)
action:
  title:
    v: Arsenic (As)
action:
  title:
    v: Lead (Pb)

prefix:
  v: Single Stage
title:
  v: Residual Solvents
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134002
    display:
      v: Residual Solvent
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-004

prefix:
  v: Single Stage
title:
  v: Impurity: Insoluble Matter
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-005

prefix:
  v: Single Stage
title:
  v: Solubility in H2O
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C60821
    display:
      v: Solubility
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-006

v: low

Quantity
value:
  v: 3.4
comparator:
  v: >=
unit:
  v: [pH]
system:
  v: http://unitsofmeasure.org
code:
  v: [pH]

v: high

Quantity
value:
  v: 4.3
comparator:
  v: <=
unit:
  v: [pH]
system:
  v: http://unitsofmeasure.org
code:
  v: [pH]

v: Identification

coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C96103
  display:
    v: Proprietary
text:
  v: FTIR

extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
  value: positiveInt
    v: 1
coding:
  system:
    v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
  code:
    v: C138993
  display:
    v: Identification

type:
  v: documentation
label:
  v: EX-TEST-102

prefix:
  v: Single Stage
title:
  v: [pH]
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205029
    display:
      v: pH
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-103

prefix:
  v: Single Stage
title:
  v: Residue on Ignition
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134276
    display:
      v: Residue on Ignition
documentation:
  type:
    v: documentation
  label:
    v: USP <281>

v: EX-TEST-202

prefix:
  v: Single Stage
title:
  v: Smell and taste
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Smell
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205026
    display:
      v: Organoleptic
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C139027
    display:
      v: Odor
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-203

prefix:
  v: Single Stage
title:
  v: Total hardness
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Titration
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134264
    display:
      v: Hardness
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-204