Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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: eCTD Document for 32S23 - TTL Representation

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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:Bundle ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "7ce2088d-d281-4e2f-9a25-120a1f9805d1"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23>     ] )
  ] ; # 
  fhir:identifier [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:7ce2088d-d281-4e2f-9a25-120a1f9805d1" ]
  ] ; # 
  fhir:type [ fhir:v "document"] ; # 
  fhir:timestamp [ fhir:v "2023-12-05T01:34:39.503Z"^^xsd:dateTime] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:d3a11b25-e160-4688-b807-6383364096fd> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519> )
  ] ) . # 

<urn:uuid:5c0d341e-6e4f-457c-811d-cfaf3eb62ecd> a fhir:Composition ;
  fhir:id [ fhir:v "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd</b></p><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd\"> </a><a name=\"5c0d341e-6e4f-457c-811d-cfaf3eb62ecd-en-US\"> </a><p><b>identifier</b>: materials1</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use ich_3.2.s.2.3}\">Control of Materials</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-49438799-e286-432c-b8d8-68ac77e7f519\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>title</b>: Control of Materials Example</p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "materials1" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ich_3.2.s.2.3" ] ;
fhir:display [ fhir:v "Control of Materials" ]     ] )
  ] ; # 
  fhir:subject ( [
fhir:reference [ fhir:v "urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a" ]
  ] ) ; # 
  fhir:date [ fhir:v "2023-12-05T01:34:39.502Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:reference [ fhir:v "urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519" ]
  ] ) ; # 
  fhir:title [ fhir:v "Control of Materials Example"] ; # 
  fhir:section ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ich_3.2.s.3.1" ] ;
fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ich_3.2.s.3.1" ] ;
fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b" ]     ] )
  ] [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ich_3.2.s.3.1" ] ;
fhir:display [ fhir:v "Elucidation of Structure and other Characteristics" ]       ] )     ] ;
    ( fhir:entry [
fhir:reference [ fhir:v "urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89" ]     ] )
  ] ) . # 

<urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "cd84a8b5-4e96-551c-15c6-c97c943eb38a"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"hccd84a8b5-4e96-551c-15c6-c97c943eb38a\"> </a><a name=\"cd84a8b5-4e96-551c-15c6-c97c943eb38a-en-US\"> </a><p><b>identifier</b>: salicylate</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov R16CO5Y76E}\">R16CO5Y76E</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C97054}\">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "salicylate" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134006" ] ;
fhir:display [ fhir:v "USP-NF" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "R16CO5Y76E" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "ACETYLSALICYLIC ACID" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C97054" ] ;
fhir:display [ fhir:v "Generic Name" ]       ] )     ]
  ] [
fhir:name [ fhir:v "ASPIRIN" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) . # 

<urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579> a fhir:Organization ;
  fhir:id [ fhir:v "4b565cf3-5353-48af-8cd6-5ccf4e9fd579"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579-en-US\"> </a><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134003" ] ;
fhir:display [ fhir:v "DUNS" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "783452221" ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134004" ] ;
fhir:display [ fhir:v "FEI" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ;
fhir:value [ fhir:v "6913973" ]
  ] ) ; # 
  fhir:name [ fhir:v "Manufacturing Site (J. Jones Research)"] ; # 
  fhir:contact ( [
fhir:address [
fhir:type [ fhir:v "postal" ] ;
fhir:text [ fhir:v "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States" ] ;
      ( fhir:line [ fhir:v "444 Grant Street" ] ) ;
fhir:city [ fhir:v "Bedford" ] ;
fhir:state [ fhir:v "NY" ] ;
fhir:postalCode [ fhir:v "15600" ] ;
fhir:country [ fhir:v "USA" ]     ]
  ] ) . # 

<urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> a fhir:Organization ;
  fhir:id [ fhir:v "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5-en-US\"> </a><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134003" ] ;
fhir:display [ fhir:v "DUNS" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "143265222" ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134004" ] ;
fhir:display [ fhir:v "FEI" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ;
fhir:value [ fhir:v "6981397" ]
  ] ) ; # 
  fhir:name [ fhir:v "Vidinaid"] ; # 
  fhir:contact ( [
fhir:address [
fhir:type [ fhir:v "postal" ] ;
fhir:text [ fhir:v "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA" ] ;
      ( fhir:line [ fhir:v "100 Stillwater Avenue" ] [ fhir:v "Building #2" ] ) ;
fhir:city [ fhir:v "Bangor" ] ;
fhir:state [ fhir:v "ME" ] ;
fhir:postalCode [ fhir:v "04401" ] ;
fhir:country [ fhir:v "USA" ]     ]
  ] ) . # 

<urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> a fhir:Organization ;
  fhir:id [ fhir:v "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049-en-US\"> </a><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134003" ] ;
fhir:display [ fhir:v "DUNS" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "173265332" ]
  ] ) ; # 
  fhir:name [ fhir:v "Mega Chem Supply"] ; # 
  fhir:contact ( [
fhir:address [
fhir:type [ fhir:v "postal" ] ;
fhir:text [ fhir:v "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States" ] ;
      ( fhir:line [ fhir:v "350 W Main Street" ] ) ;
fhir:city [ fhir:v "Rochester" ] ;
fhir:state [ fhir:v "NY" ] ;
fhir:postalCode [ fhir:v "14608" ] ;
fhir:country [ fhir:v "USA" ]     ]
  ] ) . # 

<urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "0efb1188-04f0-44ba-bfe7-ca6169ca8703"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703</b></p><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"hc0efb1188-04f0-44ba-bfe7-ca6169ca8703\"> </a><a name=\"0efb1188-04f0-44ba-bfe7-ca6169ca8703-en-US\"> </a><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C103206}\">Structurally Diverse Substance</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 5C69YCD2YJ}\">5C69YCD2YJ</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>Carrageenan</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C14258}\">Plant</span></td><td><span title=\"Codes:\">palmaria</span></td><td><span title=\"Codes:\">palmata</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 USA}\">United States of America</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "carrageenan" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C103206" ] ;
fhir:display [ fhir:v "Structurally Diverse Substance" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134009" ] ;
fhir:display [ fhir:v "Company Standard" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "5C69YCD2YJ" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "Carrageenan" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) ; # 
  fhir:sourceMaterial [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C14258" ] ;
fhir:display [ fhir:v "Plant" ]       ] )     ] ;
fhir:genus [
fhir:text [ fhir:v "palmaria" ]     ] ;
fhir:species [
fhir:text [ fhir:v "palmata" ]     ] ;
    ( fhir:countryOfOrigin [
      ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "USA" ] ;
fhir:display [ fhir:v "United States of America" ]       ] )     ] )
  ] . # 

<urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "fd84a8b5-9e96-451c-a5c6-097c943eb38a"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"hcfd84a8b5-9e96-451c-a5c6-097c943eb38a\"> </a><a name=\"fd84a8b5-9e96-451c-a5c6-097c943eb38a-en-US\"> </a><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov XF417D3PSL}\">XF417D3PSL</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ANHYDROUS CITRIC ACID</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "Citric acid" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134009" ] ;
fhir:display [ fhir:v "Company Standard" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ]
  ] ) ; # 
  fhir:supplier ( [
fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "XF417D3PSL" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "ANHYDROUS CITRIC ACID" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) ; # 
  fhir:sourceMaterial [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]       ] )     ]
  ] . # 

<urn:uuid:d3a11b25-e160-4688-b807-6383364096fd> a fhir:SubstanceDefinition ;
  fhir:id [ fhir:v "d3a11b25-e160-4688-b807-6383364096fd"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_d3a11b25-e160-4688-b807-6383364096fd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name=\"d3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"hcd3a11b25-e160-4688-b807-6383364096fd\"> </a><a name=\"d3a11b25-e160-4688-b807-6383364096fd-en-US\"> </a><p><b>identifier</b>: water</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}\">BP</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}\">059QF0KO0R</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WATER</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "water" ]
  ] ) ; # 
  fhir:classification ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]     ] )
  ] ) ; # 
  fhir:grade ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C176793" ] ;
fhir:display [ fhir:v "BP" ]     ] )
  ] ) ; # 
  fhir:manufacturer ( [
fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ]
  ] ) ; # 
  fhir:supplier ( [
fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ]
  ] ) ; # 
  fhir:code ( [
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:code [ fhir:v "059QF0KO0R" ]       ] )     ]
  ] ) ; # 
  fhir:name ( [
fhir:name [ fhir:v "WATER" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C203355" ] ;
fhir:display [ fhir:v "GSRS Preferred Term" ]       ] )     ] ;
fhir:preferred [ fhir:v "true"^^xsd:boolean ]
  ] ) ; # 
  fhir:sourceMaterial [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48807" ] ;
fhir:display [ fhir:v "Chemical" ]       ] )     ]
  ] . # 

<urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e> a fhir:PlanDefinition ;
  fhir:id [ fhir:v "ab241f8c-d21e-4382-a70a-52190dbdf07e"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_ab241f8c-d21e-4382-a70a-52190dbdf07e\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">ab241f8c-d21e-4382-a70a-52190dbdf07e</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>RawCitricacid</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Raw Material (Carrageenan) Specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-11-28</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification A:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification B:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification C:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Identification D:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Microbial Limits:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Bacterial Count:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Salmonella:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Escherichia Coli:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Elemental Impurities:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Cadmium (Cd):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Mercury (Hg):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Arsenic (As):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Lead (Pb):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residual Solvents:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Impurity: Insoluble Matter:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Solubility in H2O:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]       ] )     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "RawCitricacid" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0"] ; # 
  fhir:title [ fhir:v "Raw Material (Carrageenan) Specification Example"] ; # 
  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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C133931" ] ;
fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:reference [ fhir:v "urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703" ]
  ] ; # 
  fhir:date [ fhir:v "2023-11-28"^^xsd:date] ; # 
  fhir:goal ( [
fhir:id [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] ;
fhir:description [
fhir:text [ fhir:v "Viscous upon cooling" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Viscous upon cooling" ]     ] )
  ] [
fhir:id [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] ;
fhir:description [
fhir:text [ fhir:v "Kappa, iota or lambda" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Kappa, iota or Lambda" ]     ] )
  ] [
fhir:id [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] ;
fhir:description [
fhir:text [ fhir:v "Blue, stringy precipitate forms" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Blue stringy precipitate forms" ]     ] )
  ] [
fhir:id [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] ;
fhir:description [
fhir:text [ fhir:v "FTIR matches standard" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "FTIR matches standard" ]     ] )
  ] [
fhir:id [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] ;
fhir:description [
fhir:text [ fhir:v "max 200 cfu/g" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "200"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "colony forming unit" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "[CFU]" ]       ]     ] )
  ] [
fhir:id [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] ;
fhir:description [
fhir:text [ fhir:v "Negative" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Negative" ]     ] )
  ] [
fhir:id [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] ;
fhir:description [
fhir:text [ fhir:v "Negative" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Negative" ]     ] )
  ] [
fhir:id [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] ;
fhir:description [
fhir:text [ fhir:v "As Reported" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "As Reported" ]     ] )
  ] [
fhir:id [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] ;
fhir:description [
fhir:text [ fhir:v "As Reported" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "As Reported" ]     ] )
  ] [
fhir:id [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] ;
fhir:description [
fhir:text [ fhir:v "<= 3 ppm" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "3"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "part per million" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "[ppm]" ]       ]     ] )
  ] [
fhir:id [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] ;
fhir:description [
fhir:text [ fhir:v "<= 10 ppm" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "10"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "part per million" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "[ppm]" ]       ]     ] )
  ] [
fhir:id [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] ;
fhir:description [
fhir:text [ fhir:v "As Reported" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "As Reported" ]     ] )
  ] [
fhir:id [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] ;
fhir:description [
fhir:text [ fhir:v "<= 2.0%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "2"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "percent" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ]       ]     ] )
  ] [
fhir:id [ fhir:v "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] ;
fhir:description [
fhir:text [ fhir:v "<30ml H2O @ 25C" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "30"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "milliliter" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mL" ]       ]     ] [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "25"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "degree Celsius" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "Cel" ]       ]     ] )
  ] ) ; # 
  fhir:action ( [
fhir:id [ fhir:v "428fa917-a7d3-4515-9b48-c9366acd673a" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Identification" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C138993" ] ;
fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-001" ]     ] ) ;
    ( fhir:action [
fhir:title [ fhir:v "Identification A" ] ;
      ( fhir:goalId [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] )     ] [
fhir:title [ fhir:v "Identification B" ] ;
      ( fhir:goalId [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] )     ] [
fhir:title [ fhir:v "Identification C" ] ;
      ( fhir:goalId [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] )     ] [
fhir:title [ fhir:v "Identification D" ] ;
      ( fhir:goalId [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] )     ] )
  ] [
fhir:id [ fhir:v "f7cbb73f-4220-4987-b498-c049230091ea" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Microbial Limits" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134256" ] ;
fhir:display [ fhir:v "Microbial Limits" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-002" ]     ] ) ;
    ( fhir:action [
fhir:title [ fhir:v "Total Bacterial Count" ] ;
      ( fhir:goalId [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] )     ] [
fhir:title [ fhir:v "Salmonella" ] ;
      ( fhir:goalId [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] )     ] [
fhir:title [ fhir:v "Escherichia Coli" ] ;
      ( fhir:goalId [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] )     ] )
  ] [
fhir:id [ fhir:v "f5f8221c-f9ec-4b47-8ec7-90ff44f7388c" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Elemental Impurities" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "UV" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C204971" ] ;
fhir:display [ fhir:v "Impurity" ]       ] )     ] [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C205014" ] ;
fhir:display [ fhir:v "Elemental Impurity" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-003" ]     ] ) ;
    ( fhir:action [
fhir:title [ fhir:v "Cadmium (Cd)" ] ;
      ( fhir:goalId [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] )     ] [
fhir:title [ fhir:v "Mercury (Hg)" ] ;
      ( fhir:goalId [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] )     ] [
fhir:title [ fhir:v "Arsenic (As)" ] ;
      ( fhir:goalId [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] )     ] [
fhir:title [ fhir:v "Lead (Pb)" ] ;
      ( fhir:goalId [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] )     ] )
  ] [
fhir:id [ fhir:v "37b44e91-529a-4d87-843b-ec3dd172c09f" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Residual Solvents" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C204971" ] ;
fhir:display [ fhir:v "Impurity" ]       ] )     ] [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134002" ] ;
fhir:display [ fhir:v "Residual Solvent" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-004" ]     ] ) ;
    ( fhir:goalId [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] )
  ] [
fhir:id [ fhir:v "25a64081-a0c2-4d72-8a48-538f81fcc35f" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Impurity: Insoluble Matter" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C204971" ] ;
fhir:display [ fhir:v "Impurity" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-005" ]     ] ) ;
    ( fhir:goalId [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] )
  ] [
fhir:id [ fhir:v "055a79d2-3f6b-49ec-a129-6feac5c33812" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Solubility in H2O" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C60821" ] ;
fhir:display [ fhir:v "Solubility" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-006" ]     ] ) ;
    ( fhir:goalId [ fhir:v "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] )
  ] ) . # 

<urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b> a fhir:PlanDefinition ;
  fhir:id [ fhir:v "a2cba634-a481-4b07-9bd4-62c7ada31e1b"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_a2cba634-a481-4b07-9bd4-62c7ada31e1b\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">a2cba634-a481-4b07-9bd4-62c7ada31e1b</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>CitricAcidSpecification</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Citric acid specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-12-01</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Appearance:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Identification:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage [pH]:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Residue on Ignition:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]       ] )     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "CitricAcidSpecification" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0"] ; # 
  fhir:title [ fhir:v "Citric acid specification Example"] ; # 
  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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C133931" ] ;
fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:reference [ fhir:v "urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a" ]
  ] ; # 
  fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # 
  fhir:goal ( [
fhir:id [ fhir:v "9bc2bfdf-c9b1-440a-bafe-89f2674341d4" ] ;
fhir:description [
fhir:text [ fhir:v "White Solid" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "White solid" ]     ] )
  ] [
fhir:id [ fhir:v "59e2c94a-d383-4776-9b00-3b97b0741c9a" ] ;
fhir:description [
fhir:text [ fhir:v "IR spectrum conforms to reference standard" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "IR spectrum conforms to reference standard" ]     ] )
  ] [
fhir:id [ fhir:v "a2ed2d13-e96a-4d7b-b825-c69afd334cf7" ] ;
fhir:description [
fhir:text [ fhir:v "pH 3.4-4.3" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:_target [
      ( fhir:modifierExtension [
        ( fhir:extension [
fhir:url [ fhir:v "low"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "3.4"^^xsd:decimal ] ;
fhir:comparator [ fhir:v ">=" ] ;
fhir:unit [ fhir:v "[pH]" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "[pH]" ]           ]         ] [
fhir:url [ fhir:v "high"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "4.3"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "[pH]" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "[pH]" ]           ]         ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range"^^xsd:anyURI ]       ] )     ] )
  ] [
fhir:id [ fhir:v "e046aab8-b10f-4e13-89e6-bfa869a90b38" ] ;
fhir:description [
fhir:text [ fhir:v "residue <= 0.21%" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134030" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "0.21"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "percent" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "%" ]       ]     ] )
  ] ) ; # 
  fhir:action ( [
fhir:id [ fhir:v "fdf5e37f-ae97-48c1-9809-33aebff37199" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Appearance" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C205026" ] ;
fhir:display [ fhir:v "Organoleptic" ]       ] )     ] [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C138990" ] ;
fhir:display [ fhir:v "Description/Appearance" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-101" ]     ] ) ;
    ( fhir:goalId [ fhir:v "9bc2bfdf-c9b1-440a-bafe-89f2674341d4" ] )
  ] [
fhir:id [ fhir:v "f6da4e9e-4954-4fd1-a78a-b297fea64a6f" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Identification" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "FTIR" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C138993" ] ;
fhir:display [ fhir:v "Identification" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-102" ]     ] ) ;
    ( fhir:goalId [ fhir:v "59e2c94a-d383-4776-9b00-3b97b0741c9a" ] )
  ] [
fhir:id [ fhir:v "a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "[pH]" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C205029" ] ;
fhir:display [ fhir:v "pH" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-103" ]     ] ) ;
    ( fhir:goalId [ fhir:v "a2ed2d13-e96a-4d7b-b825-c69afd334cf7" ] )
  ] [
fhir:id [ fhir:v "aad4c3ce-985d-45ab-9d00-c2c01ca3813f" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Residue on Ignition" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96102" ] ;
fhir:display [ fhir:v "Compendial" ]       ] ) ;
fhir:text [ fhir:v "Visual" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134276" ] ;
fhir:display [ fhir:v "Residue on Ignition" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "USP <281>" ]     ] ) ;
    ( fhir:goalId [ fhir:v "e046aab8-b10f-4e13-89e6-bfa869a90b38" ] )
  ] ) . # 

<urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89> a fhir:PlanDefinition ;
  fhir:id [ fhir:v "5819b223-d3d2-419f-b617-b3a9a3625b89"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_5819b223-d3d2-419f-b617-b3a9a3625b89\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">5819b223-d3d2-419f-b617-b3a9a3625b89</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>WaterSpecification</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Water Specification Example</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C133931</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2023-12-01</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Color degree:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Turbidity:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Smell and taste:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Total hardness:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            \n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ]       ] )     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:value [ fhir:v "WaterSpecification" ]
  ] ) ; # 
  fhir:version [ fhir:v "1.0"] ; # 
  fhir:title [ fhir:v "Water Specification Example"] ; # 
  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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C133931" ] ;
fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ]     ] )
  ] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:subject [
a fhir:Reference ;
fhir:reference [ fhir:v "urn:uuid:d3a11b25-e160-4688-b807-6383364096fd" ]
  ] ; # 
  fhir:date [ fhir:v "2023-12-01"^^xsd:date] ; # 
  fhir:goal ( [
fhir:id [ fhir:v "1779ee35-8725-4322-ae82-89ed499f6864" ] ;
fhir:description [
fhir:text [ fhir:v "<=12 deg" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "12"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "degree" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "deg" ]       ]     ] )
  ] [
fhir:id [ fhir:v "2897e150-8465-48c7-9269-1cda86dc3075" ] ;
fhir:description [
fhir:text [ fhir:v "Conforms to reference standard" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Conforms to reference standard" ]     ] )
  ] [
fhir:id [ fhir:v "9c86ccba-a210-4ce5-9a23-b145d9f123c6" ] ;
fhir:description [
fhir:text [ fhir:v "Odorless" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [ fhir:v "Odorless" ]     ] )
  ] [
fhir:id [ fhir:v "de0f0d85-5617-4b07-98fc-9976b2dbf216" ] ;
fhir:description [
fhir:text [ fhir:v "<= 395mg/L" ]     ] ;
    ( fhir:addresses [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134029" ] ;
fhir:display [ fhir:v "Release" ]       ] )     ] ) ;
    ( fhir:target [
fhir:detail [
a fhir:Quantity ;
fhir:value [ fhir:v "395"^^xsd:decimal ] ;
fhir:comparator [ fhir:v "<=" ] ;
fhir:unit [ fhir:v "milligram" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mg" ]       ]     ] )
  ] ) ; # 
  fhir:action ( [
fhir:id [ fhir:v "3668eb6f-797c-4325-8f41-160c951b4adc" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Color degree" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Colorimetry" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C205026" ] ;
fhir:display [ fhir:v "Organoleptic" ]       ] )     ] [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134262" ] ;
fhir:display [ fhir:v "Color of Solution" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-201" ]     ] ) ;
    ( fhir:goalId [ fhir:v "1779ee35-8725-4322-ae82-89ed499f6864" ] )
  ] [
fhir:id [ fhir:v "42cf5de4-2c64-48fc-a4d8-9e74066c36a3" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Turbidity" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Spectrophotometer" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C74723" ] ;
fhir:display [ fhir:v "Turbidity" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-202" ]     ] ) ;
    ( fhir:goalId [ fhir:v "2897e150-8465-48c7-9269-1cda86dc3075" ] )
  ] [
fhir:id [ fhir:v "c552eee7-4dca-4a01-b291-5044d5132cc9" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Smell and taste" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Smell" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C205026" ] ;
fhir:display [ fhir:v "Organoleptic" ]       ] )     ] [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C139027" ] ;
fhir:display [ fhir:v "Odor" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-203" ]     ] ) ;
    ( fhir:goalId [ fhir:v "9c86ccba-a210-4ce5-9a23-b145d9f123c6" ] )
  ] [
fhir:id [ fhir:v "b33b402a-0dc7-4953-a7b8-aa2efeb8434f" ] ;
fhir:prefix [ fhir:v "Single Stage" ] ;
fhir:title [ fhir:v "Total hardness" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C96103" ] ;
fhir:display [ fhir:v "Proprietary" ]       ] ) ;
fhir:text [ fhir:v "Titration" ]     ] ;
    ( fhir:reason [
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ;
fhir:value [ fhir:v "1"^^xsd:positiveInteger ]       ] ) ;
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134264" ] ;
fhir:display [ fhir:v "Hardness" ]       ] )     ] ) ;
    ( fhir:documentation [
fhir:type [ fhir:v "documentation" ] ;
fhir:label [ fhir:v "EX-TEST-204" ]     ] ) ;
    ( fhir:goalId [ fhir:v "de0f0d85-5617-4b07-98fc-9976b2dbf216" ] )
  ] ) . # 

<urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519> a fhir:Organization ;
  fhir:id [ fhir:v "49438799-e286-432c-b8d8-68ac77e7f519"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_49438799-e286-432c-b8d8-68ac77e7f519\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519</b></p><a name=\"49438799-e286-432c-b8d8-68ac77e7f519\"> </a><a name=\"hc49438799-e286-432c-b8d8-68ac77e7f519\"> </a><a name=\"49438799-e286-432c-b8d8-68ac77e7f519-en-US\"> </a><p><b>identifier</b>: DUNS/143265625</p><p><b>name</b>: J. Jones Research</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>J. Jones Research, 123 Broad Way, New York, NY, United States</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C134003" ] ;
fhir:display [ fhir:v "DUNS" ]       ] )     ] ;
fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ;
fhir:value [ fhir:v "143265625" ]
  ] ) ; # 
  fhir:name [ fhir:v "J. Jones Research"] ; # 
  fhir:contact ( [
fhir:address [
fhir:type [ fhir:v "postal" ] ;
fhir:text [ fhir:v "J. Jones Research, 123 Broad Way, New York, NY, United States" ] ;
      ( fhir:line [ fhir:v "123 Broad Way" ] ) ;
fhir:city [ fhir:v "New York" ] ;
fhir:state [ fhir:v "NY" ] ;
fhir:postalCode [ fhir:v "00062" ] ;
fhir:country [ fhir:v "USA" ]     ]
  ] ) . #