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
@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 ------------------------------------------------------------------- # Substance Analytical Procedure a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundle-analytical-procedure-pq-ex2-sub"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq> ] ) ] ; # <id value="substance-analytical-procedure"/> fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c> ) ] ) . # <urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f> a fhir:PlanDefinition ; fhir:id [ fhir:v "analyticalProcedure"] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_analyticalProcedure\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </a><a name=\"hcanalyticalProcedure\"> </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 "analyticalProcedure" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</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>#analytical-procedure "Analytical Procedure")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152</p><blockquote><p><b>action</b></p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Optical properties <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#OPTICAL)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: Same as for blue light</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Theory <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#THEORY)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: MIE</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Stir Time <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-process-parameter.html\">Process Parameter Codes</a>#STIR)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1 minute</p></blockquote><p><b>title</b>: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Dispersant</span></p><p><b>role</b>: Dispersant <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#dispersant)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-manufacturing-participant-role.html\">Manufacturing Participant Role Codes</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Calculation</p><p><b>description</b>: The particle size result is calculated automatically by the instrument software for each sample.</p><p><b>code</b>: Calculation <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Reporting</p><p><b>description</b>: Report the average value as per specification</p><p><b>code</b>: Reporting <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></blockquote></blockquote></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f"^^xsd:anyURI] ; # http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f fhir:title [ fhir:v "Analytical Procedure"] ; # 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 "analytical-procedure" ] ; fhir:display [ fhir:v "Analytical Procedure" ] ] ) ] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152" ] # SubstanceDefinition\/substance1 ] ; # fhir:action ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "parameter"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/process-parameter"^^xsd:anyURI ] ; fhir:code [ fhir:v "OPTICAL" ] ; fhir:display [ fhir:v "Optical properties" ] ] ) ] ] [ fhir:url [ fhir:v "valueText"^^xsd:anyURI ] ; fhir:value [ fhir:v "Same as for blue light" ] ] ) ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "parameter"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/process-parameter"^^xsd:anyURI ] ; fhir:code [ fhir:v "THEORY" ] ; fhir:display [ fhir:v "Theory" ] ] ) ] ] [ fhir:url [ fhir:v "valueText"^^xsd:anyURI ] ; fhir:value [ fhir:v "MIE" ] ] ) ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq"^^xsd:anyURI ] ; ( fhir:extension [ fhir:url [ fhir:v "parameter"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/process-parameter"^^xsd:anyURI ] ; fhir:code [ fhir:v "STIR" ] ; fhir:display [ fhir:v "Stir Time" ] ] ) ] ] [ fhir:url [ fhir:v "value"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "1"^^xsd:decimal ] ; fhir:unit [ fhir:v "minute" ] ] # todo ucum ] ) ] ) ; fhir:title [ fhir:v "Determination of Particle Size of Stelbat by Laser Diffraction (G1112)" ] ; ( fhir:participant [ fhir:typeReference [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8135565f82" ] # SubstanceDefinition\/dispersant ] ] ) ; fhir:display [ fhir:v "Dispersant" ] ] ; fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "dispersant" ] ; fhir:display [ fhir:v "Dispersant" ] ] ) ] ] [ fhir:typeReference [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82" ] # SubstanceDefinition\/resultingMaterial ] ] ) ; fhir:display [ fhir:v "Resulting material" ] ] ; fhir:role [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"^^xsd:anyURI ] ; fhir:code [ fhir:v "ResultingMaterial" ] ; fhir:display [ fhir:v "Resulting Material" ] ] ) ] ] ) ; # can have device here or as ObsDef.device ( fhir:action [ fhir:title [ fhir:v "Sample Preparation" ] ; ( fhir:action [ fhir:title [ fhir:v "Instructions" ] ; fhir:description [ fhir:v "Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use." ] ] ) ] [ fhir:title [ fhir:v "Sample Analysis" ] ; ( fhir:action [ fhir:code [ fhir:text [ fhir:v "Test" ] ] ; fhir:definition [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI ; fhir:link <http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e> ] # ObservationDefinition\/ParticleSize ] ) ] [ fhir:title [ fhir:v "Sample Calculation" ] ; fhir:description [ fhir:v "The particle size result is calculated automatically by the instrument software for each sample." ] ; fhir:code [ fhir:text [ fhir:v "Calculation" ] ] ] [ fhir:title [ fhir:v "Reporting" ] ; fhir:description [ fhir:v "Report the average value as per specification" ] ; fhir:code [ fhir:text [ fhir:v "Reporting" ] ] ] ) ] ) . # <urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "c458791f-7cb8-428e-83f7-8a205f821152"] ; # substance1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"c458791f-7cb8-428e-83f7-8a205f821152\"> </a><a name=\"hcc458791f-7cb8-428e-83f7-8a205f821152\"> </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 SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>" ] ; # fhir:name ( [ fhir:name [ fhir:v "Stelbatolol" ] ] ) . # <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8135565f82"] ; # dispersant fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8135565f82\"> </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 SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8135565f82" </p></div><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Shelf life <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>Refer to local laboratory expiration date (may be extended with supporting data) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)</td></tr></table></div>" ] ; # fhir:property ( [ fhir:type [ fhir:text [ fhir:v "Shelf life" ] ] ; fhir:value [ a fhir:CodeableConcept ; fhir:text [ fhir:v "Refer to local laboratory expiration date (may be extended with supporting data)" ] ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)" ] ] ) . # <urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "9f69ec9c-5fd1-30d2-0790-9e8035565f82"] ; # resultingMaterial fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </a><a name=\"hc9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </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 SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f82" </p></div><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbat in dispersant (approximately 10 mg/mL)</td></tr></table></div>" ] ; # fhir:name ( [ fhir:name [ fhir:v "Stelbat in dispersant (approximately 10 mg/mL)" ] ] ) . # <urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4136-3c1f-b8ba6a7d046e"] ; # ParticleSize fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </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 ObservationDefinition "12e7e672-40a6-4136-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size</p><p><b>status</b>: active</p><p><b>description</b>: Number of Analyses: 1 replicate for each sample preparation</p><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</p><p><b>device</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c</p><p><b>hasMember</b>: </p><ul><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</li></ul></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e fhir:title [ fhir:v "Particle Size"] ; # fhir:status [ fhir:v "active"] ; # fhir:description [ fhir:v "Number of Analyses: 1 replicate for each sample preparation"] ; # fhir:code [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/data-absent-reason"^^xsd:anyURI ] ; fhir:value [ fhir:v "unsupported" ] ] ) ] ; # fhir:specimen ( [ fhir:reference [ fhir:v "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" ] # SpecimenDefinition\/specimendefinition ] ) ; # fhir:device ( [ fhir:reference [ fhir:v "DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c" ] # DeviceDefinition\/laser ] ) ; # fhir:hasMember ( [ fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e" ] # ObservationDefinition\/ParticleSizeObscuration ] [ fhir:reference [ fhir:v "ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e" ] # ObservationDefinition\/ParticleRI ] [ fhir:reference [ fhir:v "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e" ] # ObservationDefinition\/ParticleSizeRSD ] ) . # <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d045e"] ; # ParticleSizeObscuration fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </a><a name=\"hc12e7e672-40a6-4036-3c1f-b8ba6a7d045e\"> </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 ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Obscuration</p><p><b>status</b>: active</p><p><b>code</b>: Obscuration (%) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Obscuration "Obscuration")</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>10-30 %</td></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e fhir:title [ fhir:v "Obscuration"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; fhir:code [ fhir:v "Obscuration" ] ; fhir:display [ fhir:v "Obscuration" ] ] ) ; fhir:text [ fhir:v "Obscuration (%)" ] ] ; # fhir:qualifiedValue ( [ fhir:range [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq"^^xsd:anyURI ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "15"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ] ] ) ; fhir:low [ fhir:value [ fhir:v "10"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ] ; fhir:high [ fhir:value [ fhir:v "30"^^xsd:decimal ] ; fhir:unit [ fhir:v "%" ] ] ] ] ) . # <urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-41a6-4036-3c1f-b8ba6a7d045e"] ; # ParticleRI fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </a><a name=\"hc12e7e672-41a6-4036-3c1f-b8ba6a7d045e\"> </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 ObservationDefinition "12e7e672-41a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Particle refractive index</p><p><b>status</b>: active</p><p><b>code</b>: Particle refractive index <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Refractive index "Refractive index")</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>1.75-1.75</td></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e fhir:title [ fhir:v "Particle refractive index"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; fhir:code [ fhir:v "Refractive index" ] ; fhir:display [ fhir:v "Refractive index" ] ] ) ; fhir:text [ fhir:v "Particle refractive index" ] ] ; # fhir:qualifiedValue ( [ fhir:range [ fhir:low [ fhir:value [ fhir:v "1.75"^^xsd:decimal ] ] ; # unitless fhir:high [ fhir:value [ fhir:v "1.75"^^xsd:decimal ] ] # unitless ] ] ) . # <urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e> a fhir:ObservationDefinition ; fhir:id [ fhir:v "12e7e672-40a6-4036-3c1f-b8ba6a7d046e"] ; # ParticleSizeRSD fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </a><a name=\"hc12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </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 ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size RSD</p><p><b>status</b>: active</p><p><b>code</b>: Particle Size RSD <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq-example.html\">Example Local Codes - Drug</a>#Particle Size RSD)</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"^^xsd:anyURI] ; # http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e fhir:title [ fhir:v "Particle Size RSD"] ; # fhir:status [ fhir:v "active"] ; # fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"^^xsd:anyURI ] ; fhir:code [ fhir:v "Particle Size RSD" ] ; fhir:display [ fhir:v "Particle Size RSD" ] ] ) ; fhir:text [ fhir:v "Particle Size RSD" ] ] ; # fhir:qualifiedValue ( [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq"^^xsd:anyURI ] ; fhir:value [ fhir:v "The %RSD for the D(v, 0.9) must be not more than 15%" ] ] ) ] ) . # <urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2> a fhir:SpecimenDefinition ; fhir:id [ fhir:v "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"] ; # specimendefinition fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </a><a name=\"hc3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </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 SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 3</p></div>" ] ; # fhir:url [ fhir:v "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"^^xsd:anyURI] ; # http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 fhir:status [ fhir:v "active"] ; # fhir:description [ fhir:v "Number of Preparations: 3"] . # <urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c> a fhir:DeviceDefinition ; fhir:id [ fhir:v "82a39a18-91cf-a19d-76c1-a9e8bad9495c"] ; # laser fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name=\"82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </a><a name=\"hc82a39a18-91cf-a19d-76c1-a9e8bad9495c\"> </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 DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9495c" </p></div><p><b>description</b>: Analyzer with disperser and temperature control accessory, or equivalent</p><h3>Classifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size Analyzer with Laser Diffraction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>" ] ; # fhir:description [ fhir:v "Analyzer with disperser and temperature control accessory, or equivalent"] ; # fhir:classification ( [ fhir:type [ fhir:text [ fhir:v "Particle Size Analyzer with Laser Diffraction" ] ] ] ) . #
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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