Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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

: PQCMC Product Characteristic - XML Representation

Draft as of 2024-10-30

Raw xml | Download


<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>