Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, 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-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: Code System PQCMC Comp Section Types - TTL Representation

Active as of 2024-04-04

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

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

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "pqcmc-comp-section-types"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This case-sensitive code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">32S10<a name=\"pqcmc-comp-section-types-32S10\"> </a></td><td>Substance General Information</td></tr><tr><td style=\"white-space:nowrap\">32S11<a name=\"pqcmc-comp-section-types-32S11\"> </a></td><td>Substance Nomenclature</td></tr><tr><td style=\"white-space:nowrap\">32S12<a name=\"pqcmc-comp-section-types-32S12\"> </a></td><td>Substance Structure</td></tr><tr><td style=\"white-space:nowrap\">32S13<a name=\"pqcmc-comp-section-types-32S13\"> </a></td><td>Substance General Properties</td></tr><tr><td style=\"white-space:nowrap\">32S20<a name=\"pqcmc-comp-section-types-32S20\"> </a></td><td>Substance Manufacture</td></tr><tr><td style=\"white-space:nowrap\">32S21<a name=\"pqcmc-comp-section-types-32S21\"> </a></td><td>Substance Manufacturers</td></tr><tr><td style=\"white-space:nowrap\">32S22<a name=\"pqcmc-comp-section-types-32S22\"> </a></td><td>Substance Description of Manufacturing Process and Process Controls</td></tr><tr><td style=\"white-space:nowrap\">32S23<a name=\"pqcmc-comp-section-types-32S23\"> </a></td><td>Substance Control of Materials</td></tr><tr><td style=\"white-space:nowrap\">32S231<a name=\"pqcmc-comp-section-types-32S231\"> </a></td><td>Raw Material Specification</td></tr><tr><td style=\"white-space:nowrap\">32S24<a name=\"pqcmc-comp-section-types-32S24\"> </a></td><td>Substance Controls of Critical Steps and Intermediates</td></tr><tr><td style=\"white-space:nowrap\">32S25<a name=\"pqcmc-comp-section-types-32S25\"> </a></td><td>Substance Process Validation and/or Evaluation</td></tr><tr><td style=\"white-space:nowrap\">32S26<a name=\"pqcmc-comp-section-types-32S26\"> </a></td><td>Substance Manufacturing Process Development</td></tr><tr><td style=\"white-space:nowrap\">32S30<a name=\"pqcmc-comp-section-types-32S30\"> </a></td><td>Substance Characterization</td></tr><tr><td style=\"white-space:nowrap\">32S31<a name=\"pqcmc-comp-section-types-32S31\"> </a></td><td>Substance Elucidation of Structure and other Characteristics</td></tr><tr><td style=\"white-space:nowrap\">32S32<a name=\"pqcmc-comp-section-types-32S32\"> </a></td><td>Substance Impurities</td></tr><tr><td style=\"white-space:nowrap\">32S40<a name=\"pqcmc-comp-section-types-32S40\"> </a></td><td>Substance Control of Drug Substance</td></tr><tr><td style=\"white-space:nowrap\">32S41<a name=\"pqcmc-comp-section-types-32S41\"> </a></td><td>Substance Specification</td></tr><tr><td style=\"white-space:nowrap\">32S42<a name=\"pqcmc-comp-section-types-32S42\"> </a></td><td>Substance Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32S43<a name=\"pqcmc-comp-section-types-32S43\"> </a></td><td>Substance Validation of Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32S44<a name=\"pqcmc-comp-section-types-32S44\"> </a></td><td>Substance Batch Analyses</td></tr><tr><td style=\"white-space:nowrap\">32S45<a name=\"pqcmc-comp-section-types-32S45\"> </a></td><td>Substance Justification of Specification</td></tr><tr><td style=\"white-space:nowrap\">32S50<a name=\"pqcmc-comp-section-types-32S50\"> </a></td><td>Substance Reference Standards or Materials</td></tr><tr><td style=\"white-space:nowrap\">32S60<a name=\"pqcmc-comp-section-types-32S60\"> </a></td><td>Substance Container Closure System</td></tr><tr><td style=\"white-space:nowrap\">32S70<a name=\"pqcmc-comp-section-types-32S70\"> </a></td><td>Substance Stability</td></tr><tr><td style=\"white-space:nowrap\">32S71<a name=\"pqcmc-comp-section-types-32S71\"> </a></td><td>Substance Stability Summary and Conclusions</td></tr><tr><td style=\"white-space:nowrap\">32S72<a name=\"pqcmc-comp-section-types-32S72\"> </a></td><td>Substance Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td style=\"white-space:nowrap\">32S73<a name=\"pqcmc-comp-section-types-32S73\"> </a></td><td>Substance Stability Data</td></tr><tr><td style=\"white-space:nowrap\">32P10<a name=\"pqcmc-comp-section-types-32P10\"> </a></td><td>Product Description and Composition of the Drug Product</td></tr><tr><td style=\"white-space:nowrap\">32P11<a name=\"pqcmc-comp-section-types-32P11\"> </a></td><td>Product Description</td></tr><tr><td style=\"white-space:nowrap\">32P12<a name=\"pqcmc-comp-section-types-32P12\"> </a></td><td>Product Composition</td></tr><tr><td style=\"white-space:nowrap\">32P13<a name=\"pqcmc-comp-section-types-32P13\"> </a></td><td>Product Container Closure Description</td></tr><tr><td style=\"white-space:nowrap\">32P20<a name=\"pqcmc-comp-section-types-32P20\"> </a></td><td>Product Pharmaceutical Development</td></tr><tr><td style=\"white-space:nowrap\">32P21<a name=\"pqcmc-comp-section-types-32P21\"> </a></td><td>Product Components of the Drug Product</td></tr><tr><td style=\"white-space:nowrap\">32P22<a name=\"pqcmc-comp-section-types-32P22\"> </a></td><td>Product Drug Product</td></tr><tr><td style=\"white-space:nowrap\">32P23<a name=\"pqcmc-comp-section-types-32P23\"> </a></td><td>Product Manufacturing Process Development</td></tr><tr><td style=\"white-space:nowrap\">32P24<a name=\"pqcmc-comp-section-types-32P24\"> </a></td><td>Product Container Closure System</td></tr><tr><td style=\"white-space:nowrap\">32P25<a name=\"pqcmc-comp-section-types-32P25\"> </a></td><td>Product Microbiological Attributes</td></tr><tr><td style=\"white-space:nowrap\">32P26<a name=\"pqcmc-comp-section-types-32P26\"> </a></td><td>Product Compatibility</td></tr><tr><td style=\"white-space:nowrap\">32P30<a name=\"pqcmc-comp-section-types-32P30\"> </a></td><td>Product Manufacture</td></tr><tr><td style=\"white-space:nowrap\">32P31<a name=\"pqcmc-comp-section-types-32P31\"> </a></td><td>Product Manufacturers</td></tr><tr><td style=\"white-space:nowrap\">32P32<a name=\"pqcmc-comp-section-types-32P32\"> </a></td><td>Product Batch Formula</td></tr><tr><td style=\"white-space:nowrap\">32P33<a name=\"pqcmc-comp-section-types-32P33\"> </a></td><td>Product Description of Manufacturing Process and Process Controls</td></tr><tr><td style=\"white-space:nowrap\">32P34<a name=\"pqcmc-comp-section-types-32P34\"> </a></td><td>Product Controls of Critical Steps and Intermediates</td></tr><tr><td style=\"white-space:nowrap\">32P35<a name=\"pqcmc-comp-section-types-32P35\"> </a></td><td>Product Process Validation and/or Evaluation</td></tr><tr><td style=\"white-space:nowrap\">32P40<a name=\"pqcmc-comp-section-types-32P40\"> </a></td><td>Product Control of Excipients</td></tr><tr><td style=\"white-space:nowrap\">32P41<a name=\"pqcmc-comp-section-types-32P41\"> </a></td><td>Excipients Specification</td></tr><tr><td style=\"white-space:nowrap\">32P42<a name=\"pqcmc-comp-section-types-32P42\"> </a></td><td>Product Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32P43<a name=\"pqcmc-comp-section-types-32P43\"> </a></td><td>Product Validation of Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32P44<a name=\"pqcmc-comp-section-types-32P44\"> </a></td><td>Product Justification of Specifications</td></tr><tr><td style=\"white-space:nowrap\">32P45<a name=\"pqcmc-comp-section-types-32P45\"> </a></td><td>Product Excipients of Human or Animal Origin</td></tr><tr><td style=\"white-space:nowrap\">32P46<a name=\"pqcmc-comp-section-types-32P46\"> </a></td><td>Product Novel Excipients</td></tr><tr><td style=\"white-space:nowrap\">32P50<a name=\"pqcmc-comp-section-types-32P50\"> </a></td><td>Product name dosage form</td></tr><tr><td style=\"white-space:nowrap\">32P51<a name=\"pqcmc-comp-section-types-32P51\"> </a></td><td>Product Specification</td></tr><tr><td style=\"white-space:nowrap\">32P52<a name=\"pqcmc-comp-section-types-32P52\"> </a></td><td>Product Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32P53<a name=\"pqcmc-comp-section-types-32P53\"> </a></td><td>Product Validation of Analytical Procedures</td></tr><tr><td style=\"white-space:nowrap\">32P54<a name=\"pqcmc-comp-section-types-32P54\"> </a></td><td>Product Batch Analyses</td></tr><tr><td style=\"white-space:nowrap\">32P55<a name=\"pqcmc-comp-section-types-32P55\"> </a></td><td>Product Characterization of Impurities</td></tr><tr><td style=\"white-space:nowrap\">32P56<a name=\"pqcmc-comp-section-types-32P56\"> </a></td><td>Product Justification of Specifications</td></tr><tr><td style=\"white-space:nowrap\">32P60<a name=\"pqcmc-comp-section-types-32P60\"> </a></td><td>Product Reference Standards or Materials</td></tr><tr><td style=\"white-space:nowrap\">32P70<a name=\"pqcmc-comp-section-types-32P70\"> </a></td><td>Product Container Closure System</td></tr><tr><td style=\"white-space:nowrap\">32P80<a name=\"pqcmc-comp-section-types-32P80\"> </a></td><td>Product Stability</td></tr><tr><td style=\"white-space:nowrap\">32P81<a name=\"pqcmc-comp-section-types-32P81\"> </a></td><td>Product Stability Summary and Conclusion</td></tr><tr><td style=\"white-space:nowrap\">32P82<a name=\"pqcmc-comp-section-types-32P82\"> </a></td><td>Product Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td style=\"white-space:nowrap\">32P83<a name=\"pqcmc-comp-section-types-32P83\"> </a></td><td>Product Stability Data</td></tr><tr><td style=\"white-space:nowrap\">SP4151<a name=\"pqcmc-comp-section-types-SP4151\"> </a></td><td>Quality Specification</td></tr><tr><td style=\"white-space:nowrap\">SP4454<a name=\"pqcmc-comp-section-types-SP4454\"> </a></td><td>Batch Analyses</td></tr><tr><td style=\"white-space:nowrap\">SP7383<a name=\"pqcmc-comp-section-types-SP7383\"> </a></td><td>Stability Data</td></tr><tr><td style=\"white-space:nowrap\">SP7181<a name=\"pqcmc-comp-section-types-SP7181\"> </a></td><td>Stability Summary and Conclusion</td></tr></table></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/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.16.4" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0.0-ballot"] ; # 
  fhir:name [ fhir:v "PqcmcCompSectionTypes"] ; # 
  fhir:title [ fhir:v "Code System PQCMC Comp Section Types"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-04-04T12:53:15+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:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "brr@lists.HL7.org" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide.  These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems)."] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ]     ] )
  ] ) ; # 
  fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "68"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "32S10" ] ;
fhir:display [ fhir:v "Substance General Information" ]
  ] [
fhir:code [ fhir:v "32S11" ] ;
fhir:display [ fhir:v "Substance Nomenclature" ]
  ] [
fhir:code [ fhir:v "32S12" ] ;
fhir:display [ fhir:v "Substance Structure" ]
  ] [
fhir:code [ fhir:v "32S13" ] ;
fhir:display [ fhir:v "Substance General Properties" ]
  ] [
fhir:code [ fhir:v "32S20" ] ;
fhir:display [ fhir:v "Substance Manufacture" ]
  ] [
fhir:code [ fhir:v "32S21" ] ;
fhir:display [ fhir:v "Substance Manufacturers" ]
  ] [
fhir:code [ fhir:v "32S22" ] ;
fhir:display [ fhir:v "Substance Description of Manufacturing Process and Process Controls" ]
  ] [
fhir:code [ fhir:v "32S23" ] ;
fhir:display [ fhir:v "Substance Control of Materials" ]
  ] [
fhir:code [ fhir:v "32S231" ] ;
fhir:display [ fhir:v "Raw Material Specification" ]
  ] [
fhir:code [ fhir:v "32S24" ] ;
fhir:display [ fhir:v "Substance Controls of Critical Steps and Intermediates" ]
  ] [
fhir:code [ fhir:v "32S25" ] ;
fhir:display [ fhir:v "Substance Process Validation and/or Evaluation" ]
  ] [
fhir:code [ fhir:v "32S26" ] ;
fhir:display [ fhir:v "Substance Manufacturing Process Development" ]
  ] [
fhir:code [ fhir:v "32S30" ] ;
fhir:display [ fhir:v "Substance Characterization" ]
  ] [
fhir:code [ fhir:v "32S31" ] ;
fhir:display [ fhir:v "Substance Elucidation of Structure and other Characteristics" ]
  ] [
fhir:code [ fhir:v "32S32" ] ;
fhir:display [ fhir:v "Substance Impurities" ]
  ] [
fhir:code [ fhir:v "32S40" ] ;
fhir:display [ fhir:v "Substance Control of Drug Substance" ]
  ] [
fhir:code [ fhir:v "32S41" ] ;
fhir:display [ fhir:v "Substance Specification" ]
  ] [
fhir:code [ fhir:v "32S42" ] ;
fhir:display [ fhir:v "Substance Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32S43" ] ;
fhir:display [ fhir:v "Substance Validation of Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32S44" ] ;
fhir:display [ fhir:v "Substance Batch Analyses" ]
  ] [
fhir:code [ fhir:v "32S45" ] ;
fhir:display [ fhir:v "Substance Justification of Specification" ]
  ] [
fhir:code [ fhir:v "32S50" ] ;
fhir:display [ fhir:v "Substance Reference Standards or Materials" ]
  ] [
fhir:code [ fhir:v "32S60" ] ;
fhir:display [ fhir:v "Substance Container Closure System" ]
  ] [
fhir:code [ fhir:v "32S70" ] ;
fhir:display [ fhir:v "Substance Stability" ]
  ] [
fhir:code [ fhir:v "32S71" ] ;
fhir:display [ fhir:v "Substance Stability Summary and Conclusions" ]
  ] [
fhir:code [ fhir:v "32S72" ] ;
fhir:display [ fhir:v "Substance Postapproval Stability Protocol and Stability Commitment" ]
  ] [
fhir:code [ fhir:v "32S73" ] ;
fhir:display [ fhir:v "Substance Stability Data" ]
  ] [
fhir:code [ fhir:v "32P10" ] ;
fhir:display [ fhir:v "Product Description and Composition of the Drug Product" ]
  ] [
fhir:code [ fhir:v "32P11" ] ;
fhir:display [ fhir:v "Product Description" ]
  ] [
fhir:code [ fhir:v "32P12" ] ;
fhir:display [ fhir:v "Product Composition" ]
  ] [
fhir:code [ fhir:v "32P13" ] ;
fhir:display [ fhir:v "Product Container Closure Description" ]
  ] [
fhir:code [ fhir:v "32P20" ] ;
fhir:display [ fhir:v "Product Pharmaceutical Development" ]
  ] [
fhir:code [ fhir:v "32P21" ] ;
fhir:display [ fhir:v "Product Components of the Drug Product" ]
  ] [
fhir:code [ fhir:v "32P22" ] ;
fhir:display [ fhir:v "Product Drug Product" ]
  ] [
fhir:code [ fhir:v "32P23" ] ;
fhir:display [ fhir:v "Product Manufacturing Process Development" ]
  ] [
fhir:code [ fhir:v "32P24" ] ;
fhir:display [ fhir:v "Product Container Closure System" ]
  ] [
fhir:code [ fhir:v "32P25" ] ;
fhir:display [ fhir:v "Product Microbiological Attributes" ]
  ] [
fhir:code [ fhir:v "32P26" ] ;
fhir:display [ fhir:v "Product Compatibility" ]
  ] [
fhir:code [ fhir:v "32P30" ] ;
fhir:display [ fhir:v "Product Manufacture" ]
  ] [
fhir:code [ fhir:v "32P31" ] ;
fhir:display [ fhir:v "Product Manufacturers" ]
  ] [
fhir:code [ fhir:v "32P32" ] ;
fhir:display [ fhir:v "Product Batch Formula" ]
  ] [
fhir:code [ fhir:v "32P33" ] ;
fhir:display [ fhir:v "Product Description of Manufacturing Process and Process Controls" ]
  ] [
fhir:code [ fhir:v "32P34" ] ;
fhir:display [ fhir:v "Product Controls of Critical Steps and Intermediates" ]
  ] [
fhir:code [ fhir:v "32P35" ] ;
fhir:display [ fhir:v "Product Process Validation and/or Evaluation" ]
  ] [
fhir:code [ fhir:v "32P40" ] ;
fhir:display [ fhir:v "Product Control of Excipients" ]
  ] [
fhir:code [ fhir:v "32P41" ] ;
fhir:display [ fhir:v "Excipients Specification" ]
  ] [
fhir:code [ fhir:v "32P42" ] ;
fhir:display [ fhir:v "Product Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32P43" ] ;
fhir:display [ fhir:v "Product Validation of Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32P44" ] ;
fhir:display [ fhir:v "Product Justification of Specifications" ]
  ] [
fhir:code [ fhir:v "32P45" ] ;
fhir:display [ fhir:v "Product Excipients of Human or Animal Origin" ]
  ] [
fhir:code [ fhir:v "32P46" ] ;
fhir:display [ fhir:v "Product Novel Excipients" ]
  ] [
fhir:code [ fhir:v "32P50" ] ;
fhir:display [ fhir:v "Product name dosage form" ]
  ] [
fhir:code [ fhir:v "32P51" ] ;
fhir:display [ fhir:v "Product Specification" ]
  ] [
fhir:code [ fhir:v "32P52" ] ;
fhir:display [ fhir:v "Product Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32P53" ] ;
fhir:display [ fhir:v "Product Validation of Analytical Procedures" ]
  ] [
fhir:code [ fhir:v "32P54" ] ;
fhir:display [ fhir:v "Product Batch Analyses" ]
  ] [
fhir:code [ fhir:v "32P55" ] ;
fhir:display [ fhir:v "Product Characterization of Impurities" ]
  ] [
fhir:code [ fhir:v "32P56" ] ;
fhir:display [ fhir:v "Product Justification of Specifications" ]
  ] [
fhir:code [ fhir:v "32P60" ] ;
fhir:display [ fhir:v "Product Reference Standards or Materials" ]
  ] [
fhir:code [ fhir:v "32P70" ] ;
fhir:display [ fhir:v "Product Container Closure System" ]
  ] [
fhir:code [ fhir:v "32P80" ] ;
fhir:display [ fhir:v "Product Stability" ]
  ] [
fhir:code [ fhir:v "32P81" ] ;
fhir:display [ fhir:v "Product Stability Summary and Conclusion" ]
  ] [
fhir:code [ fhir:v "32P82" ] ;
fhir:display [ fhir:v "Product Postapproval Stability Protocol and Stability Commitment" ]
  ] [
fhir:code [ fhir:v "32P83" ] ;
fhir:display [ fhir:v "Product Stability Data" ]
  ] [
fhir:code [ fhir:v "SP4151" ] ;
fhir:display [ fhir:v "Quality Specification" ]
  ] [
fhir:code [ fhir:v "SP4454" ] ;
fhir:display [ fhir:v "Batch Analyses" ]
  ] [
fhir:code [ fhir:v "SP7383" ] ;
fhir:display [ fhir:v "Stability Data" ]
  ] [
fhir:code [ fhir:v "SP7181" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusion" ]
  ] ) . #