Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

: Example Container Closure - XML Representation

Raw xml | Download



<PackagedProductDefinition xmlns="http://hl7.org/fhir">
  <id value="77ad6922-9c59-43d1-93cb-29d063cc2e8c"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 77ad6922-9c59-43d1-93cb-29d063cc2e8c</b></p><a name="77ad6922-9c59-43d1-93cb-29d063cc2e8c"> </a><a name="hc77ad6922-9c59-43d1-93cb-29d063cc2e8c"> </a><a name="77ad6922-9c59-43d1-93cb-29d063cc2e8c-en-US"> </a><p><b>packageFor</b>: <a href="Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-5772a6f2-cde1-4903-bfcf-1639340205cc">Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000</a></p><p><b>description</b>: </p><div><p>Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.</p>
<p>Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults.</p>
</div><p><b>attachedDocument</b>: <a href="Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b">Bundle: identifier = UUID:8a5a9684-f8fb-4f21-a397-a1a0996b2b7f; type = document; timestamp = 2023-12-09 07:12:23+0000</a></p><h3>Packagings</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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C43169}, {http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96114}">BOTTLE</span></td></tr></table></div>
  </text>
  <packageFor>
    <reference value="urn:uuid:5772a6f2-cde1-4903-bfcf-1639340205cc"/>
  </packageFor>
  <description
               value="Plastic Bottle made of high-density polyethylene (HDPE). The plastic is chosen for its resistance to moisture and its ability to maintain the integrity of the drug.

Child-Resistant Cap: The cap features a Push-and-Turn Cap that he user to push down on the cap while turning it, which is difficult for children but manageable for adults."/>
  <attachedDocument>
    <reference value="urn:uuid:928a3bb5-7be3-4d6e-830f-1a2fc6dcee9b"/>
  </attachedDocument>
  <packaging>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C43169"/>
        <display value="BOTTLE"/>
      </coding>
      <coding>
        <system
                value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
        <code value="C96114"/>
        <display value="Child-resistant, Plastic"/>
      </coding>
    </type>
  </packaging>
</PackagedProductDefinition>