{
  "description": "Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
  "compose": {
    "include": [ {
      "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "concept": [ {
        "code": "C60819",
        "display": "Assay"
      }, {
        "code": "C204845",
        "display": "Active Ingredient Content"
      }, {
        "code": "C205001",
        "display": "Adventitious Agents (Safety)"
      }, {
        "code": "C81183",
        "display": "Amino Acid Content"
      }, {
        "code": "C205003",
        "display": "Bioburden"
      }, {
        "code": "C205007",
        "display": "Counterion Content"
      }, {
        "code": "C205015",
        "display": "Excipient"
      }, {
        "code": "C205018",
        "display": "Host Cell DNA"
      }, {
        "code": "C205020",
        "display": "In Vitro or In Vivo Test for Viral Contaminants"
      }, {
        "code": "C205028",
        "display": "Percent Conjugate"
      }, {
        "code": "C62352",
        "display": "Purity"
      }, {
        "code": "C171277",
        "display": "Nucleic Acid Content"
      }, {
        "code": "C205038",
        "display": "Solvate Content"
      }, {
        "code": "C64858",
        "display": "Total Protein"
      }, {
        "code": "C205006",
        "display": "Cell and Gene Therapy Product Characterization Assay"
      }, {
        "code": "C134249",
        "display": "Container Closure Integrity"
      }, {
        "code": "C134250",
        "display": "Uniformity"
      }, {
        "code": "C205004",
        "display": "Blend Uniformity"
      }, {
        "code": "C205019",
        "display": "IPC Content Uniformity"
      }, {
        "code": "C134115",
        "display": "Uniformity of Dosage Unit"
      }, {
        "code": "C205050",
        "display": "Uniformity in Containers"
      }, {
        "code": "C133961",
        "display": "Deliverable Volume/Fill Volume"
      }, {
        "code": "C205026",
        "display": "Organoleptic"
      }, {
        "code": "C138990",
        "display": "Description/Appearance"
      }, {
        "code": "C139027",
        "display": "Odor"
      }, {
        "code": "C134262",
        "display": "Color of Solution"
      }, {
        "code": "C134261",
        "display": "Clarity of Solution"
      }, {
        "code": "C138993",
        "display": "Identification"
      }, {
        "code": "C134252",
        "display": "Disintegration"
      }, {
        "code": "C134253",
        "display": "Dissolution"
      }, {
        "code": "C205012",
        "display": "Droplet Size"
      }, {
        "code": "C193381",
        "display": "Foreign and Particulate Matter"
      }, {
        "code": "C205024",
        "display": "Metal Detection"
      }, {
        "code": "C134255",
        "display": "Loss on Drying"
      }, {
        "code": "C134256",
        "display": "Microbial Limits"
      }, {
        "code": "C205027",
        "display": "Osmolality/Osmolarity"
      }, {
        "code": "C134257",
        "display": "Particle Size Distribution"
      }, {
        "code": "C134260",
        "display": "Bulk Density"
      }, {
        "code": "C134263",
        "display": "Conductivity"
      }, {
        "code": "C133974",
        "display": "Crystallinity"
      }, {
        "code": "C133975",
        "display": "Friability"
      }, {
        "code": "C134264",
        "display": "Hardness"
      }, {
        "code": "C63394",
        "display": "Melting Point"
      }, {
        "code": "C103201",
        "display": "Optical Rotation"
      }, {
        "code": "C205029",
        "display": "pH"
      }, {
        "code": "C60821",
        "display": "Solubility"
      }, {
        "code": "C64832",
        "display": "Specific Gravity"
      }, {
        "code": "C25483",
        "display": "Material Properties/Measurements"
      }, {
        "code": "C205022",
        "display": "Individual Weight"
      }, {
        "code": "C205017",
        "display": "Group Weight"
      }, {
        "code": "C205209",
        "display": "Average Weight"
      }, {
        "code": "C205053",
        "display": "Weight Variation"
      }, {
        "code": "C205021",
        "display": "Individual Fill Weight"
      }, {
        "code": "C205016",
        "display": "Group Fill Weight"
      }, {
        "code": "C205206",
        "display": "Average Fill Weight"
      }, {
        "code": "C205045",
        "display": "Target Group Weight Gain %"
      }, {
        "code": "C205036",
        "display": "Shell Weight"
      }, {
        "code": "C205011",
        "display": "Orifice Location"
      }, {
        "code": "C205010",
        "display": "Orifice Diameter"
      }, {
        "code": "C205009",
        "display": "Orifice Depth"
      }, {
        "code": "C205037",
        "display": "Drilled Side (Single or Double)"
      }, {
        "code": "C205025",
        "display": "Number of Orifices"
      }, {
        "code": "C205034",
        "display": "Ribbon Thickness"
      }, {
        "code": "C205033",
        "display": "Ribbon Density"
      }, {
        "code": "C205035",
        "display": "Seam Thickness"
      }, {
        "code": "C205005",
        "display": "Lock Length"
      }, {
        "code": "C205044",
        "display": "Tablet/Capsule Length"
      }, {
        "code": "C205043",
        "display": "Tablet/Capsule Diameter"
      }, {
        "code": "C205042",
        "display": "Tablet Thickness"
      }, {
        "code": "C134266",
        "display": "Tap Density"
      }, {
        "code": "C205049",
        "display": "Transdermal Properties"
      }, {
        "code": "C133979",
        "display": "Viscosity/Rheological Properties"
      }, {
        "code": "C134267",
        "display": "Plume Geometry"
      }, {
        "code": "C134269",
        "display": "Polymorphism"
      }, {
        "code": "C205030",
        "display": "Porosity"
      }, {
        "code": "C134270",
        "display": "Potency"
      }, {
        "code": "C133983",
        "display": "Pyrogenicity/Endotoxin"
      }, {
        "code": "C134272",
        "display": "Reconstitution Time"
      }, {
        "code": "C133985",
        "display": "Redispersibility"
      }, {
        "code": "C205032",
        "display": "Refractive Index"
      }, {
        "code": "C134276",
        "display": "Residue on Ignition"
      }, {
        "code": "C134277",
        "display": "Spray Pattern"
      }, {
        "code": "C134278",
        "display": "Sterility"
      }, {
        "code": "C134113",
        "display": "Syringe Functionality"
      }, {
        "code": "C134114",
        "display": "Total Organic Carbon"
      }, {
        "code": "C200004",
        "display": "Cytotoxicity"
      }, {
        "code": "C205023",
        "display": "Mechanical Integrity"
      }, {
        "code": "C205041",
        "display": "Surface Area"
      }, {
        "code": "C18951",
        "display": "Post-translational Modifications"
      }, {
        "code": "C16643",
        "display": "Glycosylation"
      }, {
        "code": "C205054",
        "display": "Thrombin Peptide Map"
      }, {
        "code": "C205031",
        "display": "Sialylation"
      }, {
        "code": "C205002",
        "display": "Amidation"
      }, {
        "code": "C205008",
        "display": "Deamidation"
      }, {
        "code": "C205000",
        "display": "Functional Assays"
      }, {
        "code": "C205013",
        "display": "Elemental Analysis"
      }, {
        "code": "C74723",
        "display": "Turbidity"
      }, {
        "code": "C204971",
        "display": "Impurity"
      }, {
        "code": "C205039",
        "display": "Specified Identified Impurity"
      }, {
        "code": "C205040",
        "display": "Specified Unidentified Impurity"
      }, {
        "code": "C205052",
        "display": "Unspecified Impurity"
      }, {
        "code": "C205047",
        "display": "Total Impurities"
      }, {
        "code": "C205048",
        "display": "Total Unknown Impurities"
      }, {
        "code": "C205051",
        "display": "Identified Impurity under IT, Monitored as Unspecified"
      }, {
        "code": "C205014",
        "display": "Elemental Impurity"
      }, {
        "code": "C204890",
        "display": "Impurity Chemical"
      }, {
        "code": "C134254",
        "display": "Impurities/Degradation Products/Related Substances"
      }, {
        "code": "C134002",
        "display": "Residual Solvent"
      } ]
    } ]
  },
  "_filename": "ValueSet-pqcmc-test-category-terminology.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2024-12-11T13:47:08+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "name": "PqcmcTestCategoryTerminology",
  "type": null,
  "experimental": "false",
  "resourceType": "ValueSet",
  "title": "Test Category Terminology",
  "package_version": "1.0.0",
  "extension": [ {
    "url": "http://hl7.org/fhir/StructureDefinition/valueset-supplement",
    "valueCanonical": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement"
  }, {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode": "brr"
  } ],
  "status": "active",
  "id": "98d0a663-d084-421a-98d2-99ac8b76b93d",
  "kind": null,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-test-category-terminology",
  "identifier": [ {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.48.28",
    "system": "urn:ietf:rfc:3986"
  } ],
  "version": "1.0.0",
  "contact": [ {
    "name": "HL7 International / Biomedical Research and Regulation",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/rcrim",
      "system": "url"
    }, {
      "value": "brr@lists.HL7.org",
      "system": "email"
    } ]
  } ]
}