{
  "description": "Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide.  These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems).",
  "_filename": "CodeSystem-pqcmc-comp-section-types.json",
  "package_name": "hl7.fhir.us.pq-cmc-fda",
  "date": "2024-04-08T17:51:06+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "content": "complete",
  "name": "PqcmcCompSectionTypes",
  "type": null,
  "experimental": "false",
  "resourceType": "CodeSystem",
  "title": "Code System PQCMC Comp Section Types",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode": "brr"
  } ],
  "status": "active",
  "id": "1b10bdd2-e42b-4f01-8bec-70a83641f19d",
  "kind": null,
  "count": 68,
  "url": "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
  "identifier": [ {
    "value": "urn:oid:2.16.840.1.113883.4.642.40.36.16.4",
    "system": "urn:ietf:rfc:3986"
  } ],
  "concept": [ {
    "code": "32S10",
    "display": "Substance General Information"
  }, {
    "code": "32S11",
    "display": "Substance Nomenclature"
  }, {
    "code": "32S12",
    "display": "Substance Structure"
  }, {
    "code": "32S13",
    "display": "Substance General Properties"
  }, {
    "code": "32S20",
    "display": "Substance Manufacture"
  }, {
    "code": "32S21",
    "display": "Substance Manufacturers"
  }, {
    "code": "32S22",
    "display": "Substance Description of Manufacturing Process and Process Controls"
  }, {
    "code": "32S23",
    "display": "Substance Control of Materials"
  }, {
    "code": "32S231",
    "display": "Raw Material Specification"
  }, {
    "code": "32S24",
    "display": "Substance Controls of Critical Steps and Intermediates"
  }, {
    "code": "32S25",
    "display": "Substance Process Validation and/or Evaluation"
  }, {
    "code": "32S26",
    "display": "Substance Manufacturing Process Development"
  }, {
    "code": "32S30",
    "display": "Substance Characterization"
  }, {
    "code": "32S31",
    "display": "Substance Elucidation of Structure and other Characteristics"
  }, {
    "code": "32S32",
    "display": "Substance Impurities"
  }, {
    "code": "32S40",
    "display": "Substance Control of Drug Substance"
  }, {
    "code": "32S41",
    "display": "Substance Specification"
  }, {
    "code": "32S42",
    "display": "Substance Analytical Procedures"
  }, {
    "code": "32S43",
    "display": "Substance Validation of Analytical Procedures"
  }, {
    "code": "32S44",
    "display": "Substance Batch Analyses"
  }, {
    "code": "32S45",
    "display": "Substance Justification of Specification"
  }, {
    "code": "32S50",
    "display": "Substance Reference Standards or Materials"
  }, {
    "code": "32S60",
    "display": "Substance Container Closure System"
  }, {
    "code": "32S70",
    "display": "Substance Stability"
  }, {
    "code": "32S71",
    "display": "Substance Stability Summary and Conclusions"
  }, {
    "code": "32S72",
    "display": "Substance Postapproval Stability Protocol and Stability Commitment"
  }, {
    "code": "32S73",
    "display": "Substance Stability Data"
  }, {
    "code": "32P10",
    "display": "Product Description and Composition of the Drug Product"
  }, {
    "code": "32P11",
    "display": "Product Description"
  }, {
    "code": "32P12",
    "display": "Product Composition"
  }, {
    "code": "32P13",
    "display": "Product Container Closure Description"
  }, {
    "code": "32P20",
    "display": "Product Pharmaceutical Development"
  }, {
    "code": "32P21",
    "display": "Product Components of the Drug Product"
  }, {
    "code": "32P22",
    "display": "Product Drug Product"
  }, {
    "code": "32P23",
    "display": "Product Manufacturing Process Development"
  }, {
    "code": "32P24",
    "display": "Product Container Closure System"
  }, {
    "code": "32P25",
    "display": "Product Microbiological Attributes"
  }, {
    "code": "32P26",
    "display": "Product Compatibility"
  }, {
    "code": "32P30",
    "display": "Product Manufacture"
  }, {
    "code": "32P31",
    "display": "Product Manufacturers"
  }, {
    "code": "32P32",
    "display": "Product Batch Formula"
  }, {
    "code": "32P33",
    "display": "Product Description of Manufacturing Process and Process Controls"
  }, {
    "code": "32P34",
    "display": "Product Controls of Critical Steps and Intermediates"
  }, {
    "code": "32P35",
    "display": "Product Process Validation and/or Evaluation"
  }, {
    "code": "32P40",
    "display": "Product Control of Excipients"
  }, {
    "code": "32P41",
    "display": "Excipients Specification"
  }, {
    "code": "32P42",
    "display": "Product Analytical Procedures"
  }, {
    "code": "32P43",
    "display": "Product Validation of Analytical Procedures"
  }, {
    "code": "32P44",
    "display": "Product Justification of Specifications"
  }, {
    "code": "32P45",
    "display": "Product Excipients of Human or Animal Origin"
  }, {
    "code": "32P46",
    "display": "Product Novel Excipients"
  }, {
    "code": "32P50",
    "display": "Product name dosage form"
  }, {
    "code": "32P51",
    "display": "Product Specification"
  }, {
    "code": "32P52",
    "display": "Product Analytical Procedures"
  }, {
    "code": "32P53",
    "display": "Product Validation of Analytical Procedures"
  }, {
    "code": "32P54",
    "display": "Product Batch Analyses"
  }, {
    "code": "32P55",
    "display": "Product Characterization of Impurities"
  }, {
    "code": "32P56",
    "display": "Product Justification of Specifications"
  }, {
    "code": "32P60",
    "display": "Product Reference Standards or Materials"
  }, {
    "code": "32P70",
    "display": "Product Container Closure System"
  }, {
    "code": "32P80",
    "display": "Product Stability"
  }, {
    "code": "32P81",
    "display": "Product Stability Summary and Conclusion"
  }, {
    "code": "32P82",
    "display": "Product Postapproval Stability Protocol and Stability Commitment"
  }, {
    "code": "32P83",
    "display": "Product Stability Data"
  }, {
    "code": "SP4151",
    "display": "Quality Specification"
  }, {
    "code": "SP4454",
    "display": "Batch Analyses"
  }, {
    "code": "SP7383",
    "display": "Stability Data"
  }, {
    "code": "SP7181",
    "display": "Stability Summary and Conclusion"
  } ],
  "caseSensitive": true,
  "version": "1.0.0-ballot",
  "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"
    } ]
  } ]
}