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 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
Draft as of 2024-10-30 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="pqcmc-product-characteristic"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-product-characteristic</b></p><a name="pqcmc-product-characteristic"> </a><a name="hcpqcmc-product-characteristic"> </a><a name="pqcmc-product-characteristic-en-US"> </a><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><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-Sterile">Sterile</a></td><td>Sterile Product Indicator</td></tr></table></li></ul></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.16"/>
</identifier>
<version value="1.0.0"/>
<name value="PqcmcProductCharacteristic"/>
<title value="PQCMC Product Characteristic"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2024-10-30T15:40:50+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="Product Characteristic for the characteristic element in ManufacturedItemDefinition for product composition."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<compose>
<include>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<concept>
<code value="OvrRelsProf"/>
<display value="Product Overall Release Profile"/>
</concept>
<concept>
<code value="OvrRelsMech"/>
<display value="Product Overall Release Mechanism"/>
</concept>
<concept>
<code value="CoatInd"/>
<display value="Coating Indicator"/>
</concept>
<concept>
<code value="TabLayCnt"/>
<display value="Tablet Layer Count"/>
</concept>
<concept>
<code value="BeaTypCnt"/>
<display value="Tablet Bead Type Count"/>
</concept>
<concept>
<code value="CapConCnt"/>
<display value="Capsule Constituent Count"/>
</concept>
<concept>
<code value="CapClass"/>
<display value="Capsule Classification Category"/>
</concept>
<concept>
<code value="Schematic"/>
<display value="Product Schematic"/>
</concept>
<concept>
<code value="WgtTyp"/>
<display value="Product Weight Type"/>
</concept>
<concept>
<code value="TotWgtNum"/>
<display value="Product Total Weight Numeric Numerator"/>
</concept>
<concept>
<code value="TotWgtDen"/>
<display value="Product Total Weight Numeric Denominator"/>
</concept>
<concept>
<code value="TotWgtTxt"/>
<display value="Total Weight Textual"/>
</concept>
<concept>
<code value="TotWgtOper"/>
<display value="Total Weight Operator"/>
</concept>
<concept>
<code value="PPiD"/>
<display value="Product Part Identifier"/>
</concept>
<concept>
<code value="PPiDref"/>
<display value="Product Part Identifier Reference"/>
</concept>
<concept>
<code value="RelsProf"/>
<display value="Product Part Release Profile"/>
</concept>
<concept>
<code value="RelsMech"/>
<display value="Product Part Release Mechanism"/>
</concept>
<concept>
<code value="CoatPurpose"/>
<display value="Coating Product Part Purpose"/>
</concept>
<concept>
<code value="Color"/>
<display value="Product Part Color Description"/>
</concept>
<concept>
<code value="ContPercent"/>
<display value="Product Part Content Percent"/>
</concept>
<concept>
<code value="AddInfo"/>
<display value="Product Part Additional Information"/>
</concept>
<concept>
<code value="StrnType"/>
<display value="Strength Type (for API)"/>
</concept>
<concept>
<code value="AmtOper"/>
<display value="Product Part Ingredient Amount Operator"/>
</concept>
<concept>
<code value="AmtText"/>
<display value="Product Part Ingredient Amount Textual"/>
</concept>
<concept>
<code value="QualStd"/>
<display value="Quality Standard"/>
</concept>
<concept>
<code value="Sterile"/>
<display value="Sterile Product Indicator"/>
</concept>
</include>
</compose>
</ValueSet>