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 |
{
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex1-validation-protocol",
"meta" : {
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🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
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"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; 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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>"
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"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/SE-UHPLCMainPeak"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/SE-UHPLCMainPeakGraph"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/SE-UHPLCHMW"
}
]
},
{
"title" : "Fill Weight Summary",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "FillWeightSummaryStep",
"display" : "Fill Weight Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/FillWeight"
}
]
},
{
"title" : "Filling Homogeneity Quality Attributes",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "FillingHomogeneityQualityAttributesStep",
"display" : "Filling Homogeneity Quality Attributes"
}
],
"text" : "Filling Homogeneity Quality Attributes"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "ObservationDefinition/conclusionHomogeneity"
}
]
},
{
"title" : "Filling Results Summary",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "FillingResultsSummaryStep",
"display" : "Filling Results Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ProteinConcentration"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/Polysorbate80Concentration"
}
]
},
{
"title" : "Statistical Evaluation of Homogeneity Data",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "StatisticalEvaluationOfHomogeneityDataStep",
"display" : "Statistical Evaluation of Homogeneity Data"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ProteinConcentrationStats"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/Polysorbate80Concentration"
}
]
},
{
"title" : "Consistency of the Lyophilization Process",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "ConsistencyoftheLyophilizationProcessStep",
"display" : "Consistency of the Lyophilization Process"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/ResidualMoisture"
},
{
"code" : {
"text" : "Definition"
},
"definitionCanonical" : "ActivityDefinition/LyophilizationAct"
}
]
},
{
"title" : "Lyophilization Homogeneity",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq",
"code" : "LyophilizationHomogeneityStep",
"display" : "Lyophilization Homogeneity Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/SE-UHPLCMainPeakLyoph"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/SE-UHPLCHMWLyoph"
}
]
}
]
}
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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