{
  "description": "This code system contains example codes for manufacturing step in PQ.",
  "_filename": "CodeSystem-cs-manufacturingStep-local-pq.json",
  "package_name": "hl7.fhir.uv.pharm-quality",
  "date": "2023-12-18T16:00:45+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "jurisdiction": [ {
    "text": "World",
    "coding": [ {
      "code": "001",
      "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "display": "World"
    } ]
  } ],
  "content": "complete",
  "name": "CsManufacturingStepPQ",
  "type": null,
  "experimental": "false",
  "resourceType": "CodeSystem",
  "title": "CodeSystem - Manufacturing Step",
  "package_version": "1.0.0-ballot",
  "extension": [ {
    "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode": "brr"
  } ],
  "status": "active",
  "id": "0ae96b0d-387e-4dbd-b1ef-f983145ec17d",
  "kind": null,
  "url": "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
  "concept": [ {
    "code": "Mixing of ingredients",
    "display": "Mixing of ingredients"
  }, {
    "code": "drying",
    "display": "Drying"
  }, {
    "code": "particleSizeReduction",
    "display": "Particle Size Reduction"
  }, {
    "code": "overall process",
    "display": "Overall Process"
  }, {
    "code": "compounding",
    "display": "Compounding Step"
  }, {
    "code": "filling",
    "display": "Filling Step"
  }, {
    "code": "lyophilization",
    "display": "Lyophilization Step"
  }, {
    "code": "release",
    "display": "Release Step"
  }, {
    "code": "Step1In-ProcessControlData",
    "display": "Step 1 In-Process Control Data"
  }, {
    "code": "Step1DSReleaseTestingResults",
    "display": "Step 1 DS Release Testing Results"
  }, {
    "code": "FormulationBufferPreparationProcessParameterStep",
    "display": "Formulation Buffer Preparation Process Parameter Step"
  }, {
    "code": "FormulationBufferPreparationPerformanceIndicatorStep",
    "display": "Formulation Buffer Preparation Performance Indicator Results"
  }, {
    "code": "ThawingandFormulationProcessParameterResultsStep",
    "display": "Thawing and Formulation Process Parameter Resultss"
  }, {
    "code": "ThawingandFormulationPerformanceIndicatorResultsStep",
    "display": "Thawing and Formulation Performance Indicator Results"
  }, {
    "code": "BioburdenReductionFiltrationProcessParameterResultsStep",
    "display": "Bioburden Reduction Filtration Process Parameter Results"
  }, {
    "code": "BioburdenReductionFiltrationPerformanceIndicatorResultsStep",
    "display": "Bioburden Reduction Filtration Performance Indicator Results"
  }, {
    "code": "MediaChallengeHoldTimesStep",
    "display": "Media Challenge Hold Times"
  }, {
    "code": "MediaChallengeResultsStep",
    "display": "Media Challenge Results"
  }, {
    "code": "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep",
    "display": "Filtered Formulated Drug Product Performance Indicator Results"
  }, {
    "code": "FillWeightSummaryStep",
    "display": "Fill Weight Summary"
  }, {
    "code": "FillingHomogeneityQualityAttributesStep",
    "display": "Filling Homogeneity Quality Attributes"
  }, {
    "code": "FillingResultsSummaryStep",
    "display": "Filling Results Summary"
  }, {
    "code": "StatisticalEvaluationOfHomogeneityDataStep",
    "display": "Statistical Evaluation of Homogeneity Data"
  }, {
    "code": "ConsistencyoftheLyophilizationProcessStep",
    "display": "Consistency of the Lyophilization Process"
  }, {
    "code": "LyophilizationHomogeneityStep",
    "display": "Lyophilization Homogeneity Results"
  } ],
  "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"
    } ]
  } ]
}