Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Active as of 2024-04-04 |
@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:ValueSet ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "pqcmc-product-characteristic"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"CodeSystem-cmc-ncit-dummy.html\"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-OvrRelsProf\">OvrRelsProf</a></td><td>Product Overall Release Profile</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-OvrRelsMech\">OvrRelsMech</a></td><td>Product Overall Release Mechanism</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-CoatInd\">CoatInd</a></td><td>Coating Indicator</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-TabLayCnt\">TabLayCnt</a></td><td>Tablet Layer Count</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-BeaTypCnt\">BeaTypCnt</a></td><td>Tablet Bead Type Count</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-CapConCnt\">CapConCnt</a></td><td>Capsule Constituent Count</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-CapClass\">CapClass</a></td><td>Capsule Classification Category</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-Schematic\">Schematic</a></td><td>Product Schematic</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-WgtTyp\">WgtTyp</a></td><td>Product Weight Type</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-TotWgtNum\">TotWgtNum</a></td><td>Product Total Weight Numeric Numerator</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-TotWgtDen\">TotWgtDen</a></td><td>Product Total Weight Numeric Denominator</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-TotWgtTxt\">TotWgtTxt</a></td><td>Total Weight Textual</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-TotWgtOper\">TotWgtOper</a></td><td>Total Weight Operator</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-PPiD\">PPiD</a></td><td>Product Part Identifier</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-PPiDref\">PPiDref</a></td><td>Product Part Identifier Reference</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-RelsProf\">RelsProf</a></td><td>Product Part Release Profile</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-RelsMech\">RelsMech</a></td><td>Product Part Release Mechanism</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-CoatPurpose\">CoatPurpose</a></td><td>Coating Product Part Purpose</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-Color\">Color</a></td><td>Product Part Color Description</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-ContPercent\">ContPercent</a></td><td>Product Part Content Percent</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-AddInfo\">AddInfo</a></td><td>Product Part Additional Information</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-StrnType\">StrnType</a></td><td>Strength Type (for API)</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-AmtOper\">AmtOper</a></td><td>Product Part Ingredient Amount Operator</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-AmtText\">AmtText</a></td><td>Product Part Ingredient Amount Textual</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-QualStd\">QualStd</a></td><td>Quality Standard</td></tr></table></li></ul></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"^^xsd:anyURI] ; #
fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.40.36.48.16" ]
] ) ; #
fhir:version [ fhir:v "1.0.0-ballot"] ; #
fhir:name [ fhir:v "PqcmcProductCharacteristic"] ; #
fhir:title [ fhir:v "Code System PQCMC Product Characteristic"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:experimental [ fhir:v "false"^^xsd:boolean] ; #
fhir:date [ fhir:v "2024-04-04T12:53:15+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "brr@lists.HL7.org" ] ] )
] ) ; #
fhir:description [ fhir:v "Product Characteristic for the characteristic element in ManufacturedItemDefinition for product composition."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ] ] )
] ) ; #
fhir:compose [
( fhir:include [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
( fhir:concept [
fhir:code [ fhir:v "OvrRelsProf" ] ;
fhir:display [ fhir:v "Product Overall Release Profile" ] ] [
fhir:code [ fhir:v "OvrRelsMech" ] ;
fhir:display [ fhir:v "Product Overall Release Mechanism" ] ] [
fhir:code [ fhir:v "CoatInd" ] ;
fhir:display [ fhir:v "Coating Indicator" ] ] [
fhir:code [ fhir:v "TabLayCnt" ] ;
fhir:display [ fhir:v "Tablet Layer Count" ] ] [
fhir:code [ fhir:v "BeaTypCnt" ] ;
fhir:display [ fhir:v "Tablet Bead Type Count" ] ] [
fhir:code [ fhir:v "CapConCnt" ] ;
fhir:display [ fhir:v "Capsule Constituent Count" ] ] [
fhir:code [ fhir:v "CapClass" ] ;
fhir:display [ fhir:v "Capsule Classification Category" ] ] [
fhir:code [ fhir:v "Schematic" ] ;
fhir:display [ fhir:v "Product Schematic" ] ] [
fhir:code [ fhir:v "WgtTyp" ] ;
fhir:display [ fhir:v "Product Weight Type" ] ] [
fhir:code [ fhir:v "TotWgtNum" ] ;
fhir:display [ fhir:v "Product Total Weight Numeric Numerator" ] ] [
fhir:code [ fhir:v "TotWgtDen" ] ;
fhir:display [ fhir:v "Product Total Weight Numeric Denominator" ] ] [
fhir:code [ fhir:v "TotWgtTxt" ] ;
fhir:display [ fhir:v "Total Weight Textual" ] ] [
fhir:code [ fhir:v "TotWgtOper" ] ;
fhir:display [ fhir:v "Total Weight Operator" ] ] [
fhir:code [ fhir:v "PPiD" ] ;
fhir:display [ fhir:v "Product Part Identifier" ] ] [
fhir:code [ fhir:v "PPiDref" ] ;
fhir:display [ fhir:v "Product Part Identifier Reference" ] ] [
fhir:code [ fhir:v "RelsProf" ] ;
fhir:display [ fhir:v "Product Part Release Profile" ] ] [
fhir:code [ fhir:v "RelsMech" ] ;
fhir:display [ fhir:v "Product Part Release Mechanism" ] ] [
fhir:code [ fhir:v "CoatPurpose" ] ;
fhir:display [ fhir:v "Coating Product Part Purpose" ] ] [
fhir:code [ fhir:v "Color" ] ;
fhir:display [ fhir:v "Product Part Color Description" ] ] [
fhir:code [ fhir:v "ContPercent" ] ;
fhir:display [ fhir:v "Product Part Content Percent" ] ] [
fhir:code [ fhir:v "AddInfo" ] ;
fhir:display [ fhir:v "Product Part Additional Information" ] ] [
fhir:code [ fhir:v "StrnType" ] ;
fhir:display [ fhir:v "Strength Type (for API)" ] ] [
fhir:code [ fhir:v "AmtOper" ] ;
fhir:display [ fhir:v "Product Part Ingredient Amount Operator" ] ] [
fhir:code [ fhir:v "AmtText" ] ;
fhir:display [ fhir:v "Product Part Ingredient Amount Textual" ] ] [
fhir:code [ fhir:v "QualStd" ] ;
fhir:display [ fhir:v "Quality Standard" ] ] ) ] )
] . #
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-04
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