Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-18 |
@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 "extensions" ] ; 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></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 "plandefinition-drug-pq-ex1-validation-protocol" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol</code></p><p><b>version</b>: 1.0.0-ballot</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-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#process-validation "Process Validation")</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>: 2023-12-18 16:00:45+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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/FiltrationPressure</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/PreFiltrationBioburden</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/PostFiltrationFilterIntegrity</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/MediaHoldTime</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/MediaBioburden</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/GrowthPromotion</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/SE-UHPLCMainPeak</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/SE-UHPLCMainPeakGraph</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/SE-UHPLCHMW</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/FillWeight</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/conclusionHomogeneity</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/ProteinConcentration</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/Polysorbate80Concentration</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/ProteinConcentrationStats</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/Polysorbate80Concentration</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/ResidualMoisture</code></td></tr><tr><td style=\"display: none\">*</td><td>Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ActivityDefinition/LyophilizationAct</code></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-cs-manufacturingStep-local-pq.html\">CodeSystem - Manufacturing Step</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><code>ObservationDefinition/SE-UHPLCMainPeakLyoph</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/SE-UHPLCHMWLyoph</code></td></tr></table></blockquote></div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0-ballot"] ; # 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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"^^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 "2023-12-18T16:00:45+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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/conclusion"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/bufferVesselMixingSpeed"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/bufferVesselMixingTime"^^xsd:anyURI ] ] ) ] ) ] [ fhir:title [ fhir:v "Formulation Buffer Preparation Performance Indicator Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/FBPPIpH"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Osmolality"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Conductivity"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Bioburden"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/BacterialEndotoxins"^^xsd:anyURI ] ] ) ] ) ] [ fhir:title [ fhir:v "Thawing and Formulation Process Parameter Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/ThawingTemp"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/ThawingTime"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/formulationVesselMixingSpeed"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/formulationVesselMixingTime"^^xsd:anyURI ] ] ) ] ) ] [ fhir:title [ fhir:v "Thawing and Formulation Performance Indicator Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/ThawingFBPPIpH"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/ThawingOsmolality"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/ThawingConductivity"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/ThawingBacterialEndotoxins"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Polysorbate"^^xsd:anyURI ] ] ) ] ) ] [ fhir:title [ fhir:v "Bioburden Reduction Filtration Process Parameter Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/FiltrationPressure"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Bioburden Reduction Filtration Performance Indicator Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/PreFiltrationBioburden"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/PostFiltrationFilterIntegrity"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Media Challenge Hold Times" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/MediaHoldTime"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Media Challenge Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/MediaBioburden"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/GrowthPromotion"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Filtered Formulated Drug Product Performance Indicator Results" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/SE-UHPLCMainPeak"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/SE-UHPLCMainPeakGraph"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/SE-UHPLCHMW"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Fill Weight Summary" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/FillWeight"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Filling Homogeneity Quality Attributes" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/conclusionHomogeneity"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Filling Results Summary" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/ProteinConcentration"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Polysorbate80Concentration"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Statistical Evaluation of Homogeneity Data" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/ProteinConcentrationStats"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/Polysorbate80Concentration"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Consistency of the Lyophilization Process" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/ResidualMoisture"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Definition" ] ] ; fhir:definition [ fhir:v "ActivityDefinition/LyophilizationAct"^^xsd:anyURI ] ] ) ] [ fhir:title [ fhir:v "Lyophilization Homogeneity" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"^^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 "ObservationDefinition/SE-UHPLCMainPeakLyoph"^^xsd:anyURI ] ] [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "ObservationDefinition/SE-UHPLCHMWLyoph"^^xsd:anyURI ] ] ) ] ) . #
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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