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

## : PlanDefinition - Drug - example, validation protocol - TTL Representation

Active as of 2024-05-08

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:PlanDefinition ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "plandefinition-drug-pq-ex1-validation-protocol"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq>     ] )
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex1-validation-protocol\"> </a><a name=\"hcplandefinition-drug-pq-ex1-validation-protocol\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition &quot;plandefinition-drug-pq-ex1-validation-protocol&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol</code></p><p><b>identifier</b>: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.1</p><p><b>version</b>: 1.0.0</p><p><b>title</b>: DP PROCESS VALIDATION</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-pharmaceutical-plan-type.html\">Pharmaceutical Plan Type Codes</a>#process-validation &quot;Process Validation&quot;)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>date</b>: 2024-05-08 12:53:57+0000</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International - Biomedical Research and Regulation: <a href=\"http://www.hl7.org/Special/committees/rcrim\">http://www.hl7.org/Special/committees/rcrim</a></p><p><b>description</b>: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...</p><p><b>jurisdiction</b>: World <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (m49.htm#001)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Formulation Buffer Preparation Process Parameter Step</p><p><b>code</b>: Formulation Buffer Preparation Process Parameter Step <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FormulationBufferPreparationProcessParameterStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Formulation Buffer Preparation Process Parameter Step</p><p><b>code</b>: FormulationBufferPreparationProcessParameterStep <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Formulation Buffer Preparation Performance Indicator Results</p><p><b>code</b>: Formulation Buffer Preparation Performance Indicator Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FormulationBufferPreparationPerformanceIndicatorStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Thawing and Formulation Process Parameter Results</p><p><b>code</b>: Thawing and Formulation Process Parameter Resultss <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#ThawingandFormulationProcessParameterResultsStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Thawing and Formulation Performance Indicator Results</p><p><b>code</b>: Thawing and Formulation Performance Indicator Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#ThawingandFormulationPerformanceIndicatorResultsStep)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: ???</p><p><b>code</b>: ??? <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Bioburden Reduction Filtration Process Parameter Results</p><p><b>code</b>: Bioburden Reduction Filtration Process Parameter Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#BioburdenReductionFiltrationProcessParameterResultsStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434\">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Bioburden Reduction Filtration Performance Indicator Results</p><p><b>code</b>: Bioburden Reduction Filtration Performance Indicator Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#BioburdenReductionFiltrationPerformanceIndicatorResultsStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434\">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434\">http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Media Challenge Hold Times</p><p><b>code</b>: Media Challenge Hold Times <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#MediaChallengeHoldTimesStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434\">http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Media Challenge Results</p><p><b>code</b>: Media Challenge Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#MediaChallengeResultsStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524\">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524\">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filtered Formulated Drug Product Performance Indicator Results</p><p><b>code</b>: Filtered Formulated Drug Product Performance Indicator Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FilteredFormulatedDrugProductPerformanceIndicatorResultsStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Fill Weight Summary</p><p><b>code</b>: Fill Weight Summary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FillWeightSummaryStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524\">http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Homogeneity Quality Attributes</p><p><b>code</b>: Filling Homogeneity Quality Attributes <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FillingHomogeneityQualityAttributesStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Conclusion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Filling Results Summary</p><p><b>code</b>: Filling Results Summary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#FillingResultsSummaryStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524\">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524\">http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Statistical Evaluation of Homogeneity Data</p><p><b>code</b>: Statistical Evaluation of Homogeneity Data <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#StatisticalEvaluationOfHomogeneityDataStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534\">http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524\">http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Consistency of the Lyophilization Process</p><p><b>code</b>: Consistency of the Lyophilization Process <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#ConsistencyoftheLyophilizationProcessStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72\">http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72</a></td></tr><tr><td style=\"display: none\">*</td><td>Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"Bundle-bundle-product-process-validation-pq-ex3-prod-bio.html\">Lyophilization</a></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Lyophilization Homogeneity</p><p><b>code</b>: Lyophilization Homogeneity Results <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-step.html\">Manufacturing Step Codes</a>#LyophilizationHomogeneityStep)</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424</a></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><a href=\"http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424\">http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424</a></td></tr></table></blockquote></div>"
      ] ; #
      fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"^^xsd:anyURI] ; #
      fhir:identifier ( [
    fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.41.34.1" ]
      ] ) ; #
      fhir:version [ fhir:v "1.0.0"] ; #
      fhir:title [ fhir:v "DP PROCESS VALIDATION"] ; #
      fhir:type [
        ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/plan-definition-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "workflow-definition" ] ;
    fhir:display [ fhir:v "Workflow Definition" ]     ] [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "process-validation" ] ;
    fhir:display [ fhir:v "Process Validation" ]     ] )
      ] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:subject [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1" ]
      ] ; #
      fhir:date [ fhir:v "2024-05-08T12:53:57+00:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
      fhir:contact ( [
    fhir:name [ fhir:v "HL7 International - Biomedical Research and Regulation" ] ;
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies..."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "001" ] ;
    fhir:display [ fhir:v "World" ]     ] ) ;
    fhir:text [ fhir:v "World" ]
      ] ) ; #
      fhir:action ( [
    fhir:title [ fhir:v "Formulation Buffer Preparation Process Parameter Step" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FormulationBufferPreparationProcessParameterStep" ] ;
    fhir:display [ fhir:v "Formulation Buffer Preparation Process Parameter Step" ]       ] ) ;
    fhir:text [ fhir:v "Formulation Buffer Preparation Process Parameter Step" ]     ] ;
        ( fhir:action [
    fhir:title [ fhir:v "Formulation Buffer Preparation Process Parameter Step" ] ;
    fhir:code [
    fhir:text [ fhir:v "FormulationBufferPreparationProcessParameterStep" ]       ] ;
          ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Conclusion" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73>         ]       ] )     ] )
      ] [
    fhir:title [ fhir:v "Formulation Buffer Preparation Performance Indicator Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FormulationBufferPreparationPerformanceIndicatorStep" ] ;
    fhir:display [ fhir:v "Formulation Buffer Preparation Performance Indicator Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:title [ fhir:v "???" ] ;
    fhir:code [
    fhir:text [ fhir:v "???" ]       ] ;
          ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424>         ]       ] )     ] )
      ] [
    fhir:title [ fhir:v "Thawing and Formulation Process Parameter Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ThawingandFormulationProcessParameterResultsStep" ] ;
    fhir:display [ fhir:v "Thawing and Formulation Process Parameter Resultss" ]       ] )     ] ;
        ( fhir:action [
    fhir:title [ fhir:v "???" ] ;
    fhir:code [
    fhir:text [ fhir:v "???" ]       ] ;
          ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73>         ]       ] )     ] )
      ] [
    fhir:title [ fhir:v "Thawing and Formulation Performance Indicator Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ThawingandFormulationPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Thawing and Formulation Performance Indicator Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:title [ fhir:v "???" ] ;
    fhir:code [
    fhir:text [ fhir:v "???" ]       ] ;
          ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424>         ]       ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]         ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434>         ]       ] )     ] )
      ] [
    fhir:title [ fhir:v "Bioburden Reduction Filtration Process Parameter Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "BioburdenReductionFiltrationProcessParameterResultsStep" ] ;
    fhir:display [ fhir:v "Bioburden Reduction Filtration Process Parameter Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434>       ]     ] )
      ] [
    fhir:title [ fhir:v "Bioburden Reduction Filtration Performance Indicator Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "BioburdenReductionFiltrationPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Bioburden Reduction Filtration Performance Indicator Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434>       ]     ] )
      ] [
    fhir:title [ fhir:v "Media Challenge Hold Times" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "MediaChallengeHoldTimesStep" ] ;
    fhir:display [ fhir:v "Media Challenge Hold Times" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434>       ]     ] )
      ] [
    fhir:title [ fhir:v "Media Challenge Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "MediaChallengeResultsStep" ] ;
    fhir:display [ fhir:v "Media Challenge Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524>       ]     ] )
      ] [
    fhir:title [ fhir:v "Filtered Formulated Drug Product Performance Indicator Results" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep" ] ;
    fhir:display [ fhir:v "Filtered Formulated Drug Product Performance Indicator Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424>       ]     ] )
      ] [
    fhir:title [ fhir:v "Fill Weight Summary" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FillWeightSummaryStep" ] ;
    fhir:display [ fhir:v "Fill Weight Summary" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524>       ]     ] )
      ] [
    fhir:title [ fhir:v "Filling Homogeneity Quality Attributes" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FillingHomogeneityQualityAttributesStep" ] ;
    fhir:display [ fhir:v "Filling Homogeneity Quality Attributes" ]       ] ) ;
    fhir:text [ fhir:v "Filling Homogeneity Quality Attributes" ]     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Conclusion" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424>       ]     ] )
      ] [
    fhir:title [ fhir:v "Filling Results Summary" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "FillingResultsSummaryStep" ] ;
    fhir:display [ fhir:v "Filling Results Summary" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524>       ]     ] )
      ] [
    fhir:title [ fhir:v "Statistical Evaluation of Homogeneity Data" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "StatisticalEvaluationOfHomogeneityDataStep" ] ;
    fhir:display [ fhir:v "Statistical Evaluation of Homogeneity Data" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524>       ]     ] )
      ] [
    fhir:title [ fhir:v "Consistency of the Lyophilization Process" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "ConsistencyoftheLyophilizationProcessStep" ] ;
    fhir:display [ fhir:v "Consistency of the Lyophilization Process" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Definition" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd>       ]     ] )
      ] [
    fhir:title [ fhir:v "Lyophilization Homogeneity" ] ;
    fhir:code [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-step"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "LyophilizationHomogeneityStep" ] ;
    fhir:display [ fhir:v "Lyophilization Homogeneity Results" ]       ] )     ] ;
        ( fhir:action [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424>       ]     ] [
    fhir:code [
    fhir:text [ fhir:v "Test" ]       ] ;
    fhir:definition [
    fhir:v "http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"^^xsd:anyURI ;
    fhir:link <http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424>       ]     ] )
      ] ) . #