Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

## : Manufacturing Step Codes - JSON Representation

Active as of 2024-05-08

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    {
      "resourceType" : "CodeSystem",
      "id" : "manufacturing-step",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/manufacturing-step</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">Mixing of ingredients<a name=\"manufacturing-step-Mixingofingredients\"> </a></td><td>Mixing of ingredients</td></tr><tr><td style=\"white-space:nowrap\">drying<a name=\"manufacturing-step-drying\"> </a></td><td>Drying</td></tr><tr><td style=\"white-space:nowrap\">particleSizeReduction<a name=\"manufacturing-step-particleSizeReduction\"> </a></td><td>Particle Size Reduction</td></tr><tr><td style=\"white-space:nowrap\">overall process<a name=\"manufacturing-step-overallprocess\"> </a></td><td>Overall Process</td></tr><tr><td style=\"white-space:nowrap\">compounding<a name=\"manufacturing-step-compounding\"> </a></td><td>Compounding Step</td></tr><tr><td style=\"white-space:nowrap\">filling<a name=\"manufacturing-step-filling\"> </a></td><td>Filling Step</td></tr><tr><td style=\"white-space:nowrap\">lyophilization<a name=\"manufacturing-step-lyophilization\"> </a></td><td>Lyophilization Step</td></tr><tr><td style=\"white-space:nowrap\">release<a name=\"manufacturing-step-release\"> </a></td><td>Release Step</td></tr><tr><td style=\"white-space:nowrap\">Step1In-ProcessControlData<a name=\"manufacturing-step-Step1In-ProcessControlData\"> </a></td><td>Step 1 In-Process Control Data</td></tr><tr><td style=\"white-space:nowrap\">Step1DSReleaseTestingResults<a name=\"manufacturing-step-Step1DSReleaseTestingResults\"> </a></td><td>Step 1 DS Release Testing Results</td></tr><tr><td style=\"white-space:nowrap\">FormulationBufferPreparationProcessParameterStep<a name=\"manufacturing-step-FormulationBufferPreparationProcessParameterStep\"> </a></td><td>Formulation Buffer Preparation Process Parameter Step</td></tr><tr><td style=\"white-space:nowrap\">FormulationBufferPreparationPerformanceIndicatorStep<a name=\"manufacturing-step-FormulationBufferPreparationPerformanceIndicatorStep\"> </a></td><td>Formulation Buffer Preparation Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">ThawingandFormulationProcessParameterResultsStep<a name=\"manufacturing-step-ThawingandFormulationProcessParameterResultsStep\"> </a></td><td>Thawing and Formulation Process Parameter Resultss</td></tr><tr><td style=\"white-space:nowrap\">ThawingandFormulationPerformanceIndicatorResultsStep<a name=\"manufacturing-step-ThawingandFormulationPerformanceIndicatorResultsStep\"> </a></td><td>Thawing and Formulation Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">BioburdenReductionFiltrationProcessParameterResultsStep<a name=\"manufacturing-step-BioburdenReductionFiltrationProcessParameterResultsStep\"> </a></td><td>Bioburden Reduction Filtration Process Parameter Results</td></tr><tr><td style=\"white-space:nowrap\">BioburdenReductionFiltrationPerformanceIndicatorResultsStep<a name=\"manufacturing-step-BioburdenReductionFiltrationPerformanceIndicatorResultsStep\"> </a></td><td>Bioburden Reduction Filtration Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">MediaChallengeHoldTimesStep<a name=\"manufacturing-step-MediaChallengeHoldTimesStep\"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style=\"white-space:nowrap\">MediaChallengeResultsStep<a name=\"manufacturing-step-MediaChallengeResultsStep\"> </a></td><td>Media Challenge Results</td></tr><tr><td style=\"white-space:nowrap\">FilteredFormulatedDrugProductPerformanceIndicatorResultsStep<a name=\"manufacturing-step-FilteredFormulatedDrugProductPerformanceIndicatorResultsStep\"> </a></td><td>Filtered Formulated Drug Product Performance Indicator Results</td></tr><tr><td style=\"white-space:nowrap\">FillWeightSummaryStep<a name=\"manufacturing-step-FillWeightSummaryStep\"> </a></td><td>Fill Weight Summary</td></tr><tr><td style=\"white-space:nowrap\">FillingHomogeneityQualityAttributesStep<a name=\"manufacturing-step-FillingHomogeneityQualityAttributesStep\"> </a></td><td>Filling Homogeneity Quality Attributes</td></tr><tr><td style=\"white-space:nowrap\">FillingResultsSummaryStep<a name=\"manufacturing-step-FillingResultsSummaryStep\"> </a></td><td>Filling Results Summary</td></tr><tr><td style=\"white-space:nowrap\">StatisticalEvaluationOfHomogeneityDataStep<a name=\"manufacturing-step-StatisticalEvaluationOfHomogeneityDataStep\"> </a></td><td>Statistical Evaluation of Homogeneity Data</td></tr><tr><td style=\"white-space:nowrap\">ConsistencyoftheLyophilizationProcessStep<a name=\"manufacturing-step-ConsistencyoftheLyophilizationProcessStep\"> </a></td><td>Consistency of the Lyophilization Process</td></tr><tr><td style=\"white-space:nowrap\">LyophilizationHomogeneityStep<a name=\"manufacturing-step-LyophilizationHomogeneityStep\"> </a></td><td>Lyophilization Homogeneity Results</td></tr></table></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        }
      ],
      "url" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
      "identifier" : [
        {
          "system" : "urn:ietf:rfc:3986",
          "value" : "urn:oid:2.16.840.1.113883.4.642.40.41.16.20"
        }
      ],
      "version" : "1.0.0",
      "name" : "CsManufacturingStep",
      "title" : "Manufacturing Step Codes",
      "status" : "active",
      "experimental" : false,
      "date" : "2024-05-08T12:53:57+00:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International - Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            }
          ]
        }
      ],
      "description" : "This code system contains codes for manufacturing step.",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
              "code" : "001",
              "display" : "World"
            }
          ],
          "text" : "World"
        }
      ],
      "caseSensitive" : true,
      "content" : "complete",
      "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"
        }
      ]
    }