Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: eCTD sections Terminology - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet cmc-comp-section-types-vs</b></p><a name=\"cmc-comp-section-types-vs\"> </a><a name=\"hccmc-comp-section-types-vs\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-ICHContextOfUse.html\"><code>http://terminology.hl7.org/CodeSystem/ICHContextOfUse</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ich_3.2.s</td><td>m3.2.s drug substance</td></tr><tr><td>ich_3.2.s.1</td><td>m3.2.s.1 general information</td></tr><tr><td>ich_3.2.s.2</td><td>m3.2.s.2 manufacture</td></tr><tr><td>ich_3.2.s.2.1</td><td>m3.2.s.2.1 manufacturer(s)</td></tr><tr><td>ich_3.2.s.2.2</td><td>m3.2.s.2.2 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.s.2.3</td><td>m3.2.s.2.3 control of materials</td></tr><tr><td>ich_3.2.s.2.4</td><td>m3.2.s.2.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.s.2.5</td><td>m3.2.s.2.5 process validation and/or  evaluation</td></tr><tr><td>ich_3.2.s.2.6</td><td>m3.2.s.2.6 manufacturing process development</td></tr><tr><td>ich_3.2.s.3</td><td>m3.2.s.3 characterisation</td></tr><tr><td>ich_3.2.s.3.1</td><td>m3.2.s.3.1 elucidation of structure and other characteristics</td></tr><tr><td>ich_3.2.s.3.2</td><td>m3.2.s.3.2 impurities</td></tr><tr><td>ich_3.2.s.4</td><td>m3.2.s.4 control of drug substance</td></tr><tr><td>ich_3.2.s.4.1</td><td>m3.2.s.4.1 specification</td></tr><tr><td>ich_3.2.s.4.2</td><td>m3.2.s.4.2 analytical procedures</td></tr><tr><td>ich_3.2.s.4.3</td><td>m3.2.s.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.s.4.4</td><td>m3.2.s.4.4 batch analyses</td></tr><tr><td>ich_3.2.s.4.5</td><td>m3.2.s.4.5 justification of specification</td></tr><tr><td>ich_3.2.s.5</td><td>m3.2.s.5 reference standards or materials</td></tr><tr><td>ich_3.2.s.6</td><td>m3.2.s.6 container closure system</td></tr><tr><td>ich_3.2.s.7</td><td>m3.2.s.7 stability</td></tr><tr><td>ich_3.2.s.7.1</td><td>m3.2.s.7.1 stability summary and conclusions</td></tr><tr><td>ich_3.2.s.7.2</td><td>m3.2.s.7.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.s.7.3</td><td>m3.2.s.7.3 stability data</td></tr><tr><td>ich_3.2.p</td><td>m3.2.p drug product</td></tr><tr><td>ich_3.2.p.1</td><td>m3.2.p.1 description and composition of the drug product</td></tr><tr><td>ich_3.2.p.2</td><td>m3.2.p.2 pharmaceutical development</td></tr><tr><td>ich_3.2.p.2.1</td><td>m3.2.p.2.1 components of the drug product</td></tr><tr><td>ich_3.2.p.2.2</td><td>m3.2.p.2.2 drug product</td></tr><tr><td>ich_3.2.p.2.3</td><td>m3.2.p.2.3 manufacturing process development</td></tr><tr><td>ich_3.2.p.2.4</td><td>m3.2.p.2.4 container closure system</td></tr><tr><td>ich_3.2.p.2.5</td><td>m3.2.p.2.5 microbiological attributes</td></tr><tr><td>ich_3.2.p.2.6</td><td>m3.2.p.2.6 compatibility</td></tr><tr><td>ich_3.2.p.3</td><td>m3.2.p.3 manufacture</td></tr><tr><td>ich_3.2.p.3.1</td><td>m3.2.p.3.1 manufacturer(s)</td></tr><tr><td>ich_3.2.p.3.2</td><td>m3.2.p.3.2 batch formula</td></tr><tr><td>ich_3.2.p.3.3</td><td>m3.2.p.3.3 description of manufacturing process and process controls</td></tr><tr><td>ich_3.2.p.3.4</td><td>m3.2.p.3.4 controls of critical steps and intermediates</td></tr><tr><td>ich_3.2.p.3.5</td><td>m3.2.p.3.5 process validation and/or  evaluation</td></tr><tr><td>ich_3.2.p.4</td><td>m3.2.p.4 control of excipients</td></tr><tr><td>ich_3.2.p.4.1</td><td>m3.2.p.4.1 specifications</td></tr><tr><td>ich_3.2.p.4.2</td><td>m3.2.p.4.2 analytical procedures</td></tr><tr><td>ich_3.2.p.4.3</td><td>m3.2.p.4.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.4.4</td><td>m3.2.p.4.4 justification of specifications</td></tr><tr><td>ich_3.2.p.4.5</td><td>m3.2.p.4.5 excipients of human or animal origin</td></tr><tr><td>ich_3.2.p.4.6</td><td>m3.2.p.4.6 novel excipients</td></tr><tr><td>ich_3.2.p.5</td><td>m3.2.p.5 control of drug product</td></tr><tr><td>ich_3.2.p.5.1</td><td>m3.2.p.5.1 specification(s)</td></tr><tr><td>ich_3.2.p.5.2</td><td>m3.2.p.5.2 analytical procedures</td></tr><tr><td>ich_3.2.p.5.3</td><td>m3.2.p.5.3 validation of analytical procedures</td></tr><tr><td>ich_3.2.p.5.4</td><td>m3.2.p.5.4 batch analyses</td></tr><tr><td>ich_3.2.p.5.5</td><td>m3.2.p.5.5 characterisation of impurities</td></tr><tr><td>ich_3.2.p.5.6</td><td>m3.2.p.5.6 justification of specifications</td></tr><tr><td>ich_3.2.p.6</td><td>m3.2.p.6 reference standards or materials</td></tr><tr><td>ich_3.2.p.7</td><td>m3.2.p.7 container closure system</td></tr><tr><td>ich_3.2.p.8</td><td>m3.2.p.8 stability</td></tr><tr><td>ich_3.2.p.8.1</td><td>m3.2.p.8.1 stability summary and conclusion</td></tr><tr><td>ich_3.2.p.8.2</td><td>m3.2.p.8.2 post-approval stability protocol and stability commitment</td></tr><tr><td>ich_3.2.p.8.3</td><td>m3.2.p.8.3 stability data</td></tr><tr><td>ich_3.2.a</td><td>m3.2.a appendices</td></tr><tr><td>ich_3.2.a.1</td><td>m3.2.a.1 facilities and equipment</td></tr><tr><td>ich_3.2.a.2</td><td>m3.2.a.2 adventitious agents safety evaluation</td></tr><tr><td>ich_3.2.a.3</td><td>m3.2.a.3 excipients</td></tr><tr><td>ich_3.2.r</td><td>m3.2 r regional information</td></tr><tr><td>ich_3.3</td><td>m3.3 literature references</td></tr></table></li></ul></div>"^^rdf:XMLLiteral
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fhir:code [ fhir:v "ich_3.2.s" ] ;
fhir:display [ fhir:v "m3.2.s drug substance" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.1" ] ;
fhir:display [ fhir:v "m3.2.s.1 general information" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2" ] ;
fhir:display [ fhir:v "m3.2.s.2 manufacture" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.1" ] ;
fhir:display [ fhir:v "m3.2.s.2.1 manufacturer(s)" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.2" ] ;
fhir:display [ fhir:v "m3.2.s.2.2 description of manufacturing process and process controls" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.3" ] ;
fhir:display [ fhir:v "m3.2.s.2.3 control of materials" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.4" ] ;
fhir:display [ fhir:v "m3.2.s.2.4 controls of critical steps and intermediates" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.5" ] ;
fhir:display [ fhir:v "m3.2.s.2.5 process validation and/or  evaluation" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.2.6" ] ;
fhir:display [ fhir:v "m3.2.s.2.6 manufacturing process development" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.3" ] ;
fhir:display [ fhir:v "m3.2.s.3 characterisation" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.3.1" ] ;
fhir:display [ fhir:v "m3.2.s.3.1 elucidation of structure and other characteristics" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.3.2" ] ;
fhir:display [ fhir:v "m3.2.s.3.2 impurities" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4" ] ;
fhir:display [ fhir:v "m3.2.s.4 control of drug substance" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.1" ] ;
fhir:display [ fhir:v "m3.2.s.4.1 specification" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.2" ] ;
fhir:display [ fhir:v "m3.2.s.4.2 analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.3" ] ;
fhir:display [ fhir:v "m3.2.s.4.3 validation of analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.4" ] ;
fhir:display [ fhir:v "m3.2.s.4.4 batch analyses" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.4.5" ] ;
fhir:display [ fhir:v "m3.2.s.4.5 justification of specification" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.5" ] ;
fhir:display [ fhir:v "m3.2.s.5 reference standards or materials" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.6" ] ;
fhir:display [ fhir:v "m3.2.s.6 container closure system" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.7" ] ;
fhir:display [ fhir:v "m3.2.s.7 stability" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.7.1" ] ;
fhir:display [ fhir:v "m3.2.s.7.1 stability summary and conclusions" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.7.2" ] ;
fhir:display [ fhir:v "m3.2.s.7.2 post-approval stability protocol and stability commitment" ]       ] [
fhir:code [ fhir:v "ich_3.2.s.7.3" ] ;
fhir:display [ fhir:v "m3.2.s.7.3 stability data" ]       ] [
fhir:code [ fhir:v "ich_3.2.p" ] ;
fhir:display [ fhir:v "m3.2.p drug product" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.1" ] ;
fhir:display [ fhir:v "m3.2.p.1 description and composition of the drug product" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2" ] ;
fhir:display [ fhir:v "m3.2.p.2 pharmaceutical development" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.1" ] ;
fhir:display [ fhir:v "m3.2.p.2.1 components of the drug product" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.2" ] ;
fhir:display [ fhir:v "m3.2.p.2.2 drug product" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.3" ] ;
fhir:display [ fhir:v "m3.2.p.2.3 manufacturing process development" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.4" ] ;
fhir:display [ fhir:v "m3.2.p.2.4 container closure system" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.5" ] ;
fhir:display [ fhir:v "m3.2.p.2.5 microbiological attributes" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.2.6" ] ;
fhir:display [ fhir:v "m3.2.p.2.6 compatibility" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3" ] ;
fhir:display [ fhir:v "m3.2.p.3 manufacture" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3.1" ] ;
fhir:display [ fhir:v "m3.2.p.3.1 manufacturer(s)" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3.2" ] ;
fhir:display [ fhir:v "m3.2.p.3.2 batch formula" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3.3" ] ;
fhir:display [ fhir:v "m3.2.p.3.3 description of manufacturing process and process controls" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3.4" ] ;
fhir:display [ fhir:v "m3.2.p.3.4 controls of critical steps and intermediates" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.3.5" ] ;
fhir:display [ fhir:v "m3.2.p.3.5 process validation and/or  evaluation" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4" ] ;
fhir:display [ fhir:v "m3.2.p.4 control of excipients" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.1" ] ;
fhir:display [ fhir:v "m3.2.p.4.1 specifications" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.2" ] ;
fhir:display [ fhir:v "m3.2.p.4.2 analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.3" ] ;
fhir:display [ fhir:v "m3.2.p.4.3 validation of analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.4" ] ;
fhir:display [ fhir:v "m3.2.p.4.4 justification of specifications" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.5" ] ;
fhir:display [ fhir:v "m3.2.p.4.5 excipients of human or animal origin" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.4.6" ] ;
fhir:display [ fhir:v "m3.2.p.4.6 novel excipients" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5" ] ;
fhir:display [ fhir:v "m3.2.p.5 control of drug product" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.1" ] ;
fhir:display [ fhir:v "m3.2.p.5.1 specification(s)" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.2" ] ;
fhir:display [ fhir:v "m3.2.p.5.2 analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.3" ] ;
fhir:display [ fhir:v "m3.2.p.5.3 validation of analytical procedures" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.4" ] ;
fhir:display [ fhir:v "m3.2.p.5.4 batch analyses" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.5" ] ;
fhir:display [ fhir:v "m3.2.p.5.5 characterisation of impurities" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.5.6" ] ;
fhir:display [ fhir:v "m3.2.p.5.6 justification of specifications" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.6" ] ;
fhir:display [ fhir:v "m3.2.p.6 reference standards or materials" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.7" ] ;
fhir:display [ fhir:v "m3.2.p.7 container closure system" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.8" ] ;
fhir:display [ fhir:v "m3.2.p.8 stability" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.8.1" ] ;
fhir:display [ fhir:v "m3.2.p.8.1 stability summary and conclusion" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.8.2" ] ;
fhir:display [ fhir:v "m3.2.p.8.2 post-approval stability protocol and stability commitment" ]       ] [
fhir:code [ fhir:v "ich_3.2.p.8.3" ] ;
fhir:display [ fhir:v "m3.2.p.8.3 stability data" ]       ] [
fhir:code [ fhir:v "ich_3.2.a" ] ;
fhir:display [ fhir:v "m3.2.a appendices" ]       ] [
fhir:code [ fhir:v "ich_3.2.a.1" ] ;
fhir:display [ fhir:v "m3.2.a.1 facilities and equipment" ]       ] [
fhir:code [ fhir:v "ich_3.2.a.2" ] ;
fhir:display [ fhir:v "m3.2.a.2 adventitious agents safety evaluation" ]       ] [
fhir:code [ fhir:v "ich_3.2.a.3" ] ;
fhir:display [ fhir:v "m3.2.a.3 excipients" ]       ] [
fhir:code [ fhir:v "ich_3.2.r" ] ;
fhir:display [ fhir:v "m3.2 r regional information" ]       ] [
fhir:code [ fhir:v "ich_3.3" ] ;
fhir:display [ fhir:v "m3.3 literature references" ]       ] )     ] )
  ] . #