Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
| Active as of 2024-05-08 |
{
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex1-validation-protocol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"text" : {
"status" : "generated",
"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 "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>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 "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>: 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>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.41.34.1"
}
],
"version" : "1.0.0",
"title" : "DP PROCESS VALIDATION",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type",
"code" : "process-validation",
"display" : "Process Validation"
}
]
},
"status" : "active",
"subjectReference" : {
🔗 "reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"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" : "Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
],
"text" : "World"
}
],
"action" : [
{
"title" : "Formulation Buffer Preparation Process Parameter Step",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FormulationBufferPreparationProcessParameterStep",
"display" : "Formulation Buffer Preparation Process Parameter Step"
}
],
"text" : "Formulation Buffer Preparation Process Parameter Step"
},
"action" : [
{
"title" : "Formulation Buffer Preparation Process Parameter Step",
"code" : {
"text" : "FormulationBufferPreparationProcessParameterStep"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/22515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e73"
}
]
}
]
},
{
"title" : "Formulation Buffer Preparation Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FormulationBufferPreparationPerformanceIndicatorStep",
"display" : "Formulation Buffer Preparation Performance Indicator Results"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d6-9fe1-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958424"
}
]
}
]
},
{
"title" : "Thawing and Formulation Process Parameter Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ThawingandFormulationProcessParameterResultsStep",
"display" : "Thawing and Formulation Process Parameter Resultss"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe2-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc17b5d5-9fe1-91c2-2d06-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d5-9fe1-92c2-2d06-47cb5b295e73"
}
]
}
]
},
{
"title" : "Thawing and Formulation Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ThawingandFormulationPerformanceIndicatorResultsStep",
"display" : "Thawing and Formulation Performance Indicator Results"
}
]
},
"action" : [
{
"title" : "???",
"code" : {
"text" : "???"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b5d6-9fe1-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515a3c-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515a3c-5134-448a-9c19-939ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b4c-5134-448a-9c19-949ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-949ce1958434"
}
]
}
]
},
{
"title" : "Bioburden Reduction Filtration Process Parameter Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "BioburdenReductionFiltrationProcessParameterResultsStep",
"display" : "Bioburden Reduction Filtration Process Parameter Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Bioburden Reduction Filtration Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "BioburdenReductionFiltrationPerformanceIndicatorResultsStep",
"display" : "Bioburden Reduction Filtration Performance Indicator Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958434"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/75515b3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Media Challenge Hold Times",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "MediaChallengeHoldTimesStep",
"display" : "Media Challenge Hold Times"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/75515c3c-5134-448a-9c19-949ce1958434"
}
]
},
{
"title" : "Media Challenge Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "MediaChallengeResultsStep",
"display" : "Media Challenge Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce1958524"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9d19-939ce1958524"
}
]
},
{
"title" : "Filtered Formulated Drug Product Performance Indicator Results",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FilteredFormulatedDrugProductPerformanceIndicatorResultsStep",
"display" : "Filtered Formulated Drug Product Performance Indicator Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a4d-5034-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a33-5034-448a-9c19-938ce1958424"
}
]
},
{
"title" : "Fill Weight Summary",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillWeightSummaryStep",
"display" : "Fill Weight Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64515b3c-5134-448a-9c19-939ce2958524"
}
]
},
{
"title" : "Filling Homogeneity Quality Attributes",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillingHomogeneityQualityAttributesStep",
"display" : "Filling Homogeneity Quality Attributes"
}
],
"text" : "Filling Homogeneity Quality Attributes"
},
"action" : [
{
"code" : {
"text" : "Conclusion"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/22525a3c-5035-448a-9c19-938ce1958424"
}
]
},
{
"title" : "Filling Results Summary",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "FillingResultsSummaryStep",
"display" : "Filling Results Summary"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958524"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"
}
]
},
{
"title" : "Statistical Evaluation of Homogeneity Data",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "StatisticalEvaluationOfHomogeneityDataStep",
"display" : "Statistical Evaluation of Homogeneity Data"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5134-448a-9c19-939ce1958534"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/74515b3c-5234-448a-9c19-939ce1958524"
}
]
},
{
"title" : "Consistency of the Lyophilization Process",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "ConsistencyoftheLyophilizationProcessStep",
"display" : "Consistency of the Lyophilization Process"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/fc27b6d6-9fe2-91c2-2d16-47cb5b295e72"
},
{
"code" : {
"text" : "Definition"
},
"definitionCanonical" : "http://example-server.com/fhir/ActivityDefinition/b664977d-799d-a1ce-928a-6def2a9955bd"
}
]
},
{
"title" : "Lyophilization Homogeneity",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/manufacturing-step",
"code" : "LyophilizationHomogeneityStep",
"display" : "Lyophilization Homogeneity Results"
}
]
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5134-448a-9c19-938ce1958424"
},
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "http://example-server.com/fhir/ObservationDefinition/64525a3d-5144-448a-9c19-938ce1958424"
}
]
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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