EMA Write PMS API Implementation Guide - Enrichments
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: Manufacturing Activity Value Set - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="100000160406"/>
  <meta>
    <versionId value="5.0.0"/>
    <lastUpdated value="2023-08-03T11:35:00.198Z"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 100000160406</b></p><a name="100000160406"> </a><a name="hc100000160406"> </a><a name="100000160406-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000160406</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">100000160407<a name="100000160406-100000160407"> </a></td><td>Manufacturer responsible for batch certification</td></tr><tr><td style="white-space:nowrap">100000160408<a name="100000160406-100000160408"> </a></td><td>Quality control testing of medicinal product</td></tr><tr><td style="white-space:nowrap">100000160409<a name="100000160406-100000160409"> </a></td><td>Microbiological testing: sterility</td></tr><tr><td style="white-space:nowrap">100000160410<a name="100000160406-100000160410"> </a></td><td>Microbiological testing: non-sterility</td></tr><tr><td style="white-space:nowrap">100000160411<a name="100000160406-100000160411"> </a></td><td>Chemical/Physical testing</td></tr><tr><td style="white-space:nowrap">100000160412<a name="100000160406-100000160412"> </a></td><td>Biological testing</td></tr><tr><td style="white-space:nowrap">100000160413<a name="100000160406-100000160413"> </a></td><td>Processing operations for the medicinal product</td></tr><tr><td style="white-space:nowrap">100000160415<a name="100000160406-100000160415"> </a></td><td>Manufacturer of solvent / diluent</td></tr><tr><td style="white-space:nowrap">100000160448<a name="100000160406-100000160448"> </a></td><td>Quality control testing of active substance</td></tr><tr><td style="white-space:nowrap">100000160449<a name="100000160406-100000160449"> </a></td><td>Microbiological testing: sterility</td></tr><tr><td style="white-space:nowrap">100000160450<a name="100000160406-100000160450"> </a></td><td>Microbiological testing: non-sterility</td></tr><tr><td style="white-space:nowrap">100000160451<a name="100000160406-100000160451"> </a></td><td>Chemical/Physical testing</td></tr><tr><td style="white-space:nowrap">100000160452<a name="100000160406-100000160452"> </a></td><td>Biological testing</td></tr><tr><td style="white-space:nowrap">100000160453<a name="100000160406-100000160453"> </a></td><td>Manufacturer of active substance intermediate</td></tr><tr><td style="white-space:nowrap">100000160454<a name="100000160406-100000160454"> </a></td><td>Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000160455<a name="100000160406-100000160455"> </a></td><td>Storage and/or distribution of active substance</td></tr><tr><td style="white-space:nowrap">100000160456<a name="100000160406-100000160456"> </a></td><td>Sterilisation</td></tr><tr><td style="white-space:nowrap">100000160457<a name="100000160406-100000160457"> </a></td><td>Filtration</td></tr><tr><td style="white-space:nowrap">100000160458<a name="100000160406-100000160458"> </a></td><td>Dry heat</td></tr><tr><td style="white-space:nowrap">100000160459<a name="100000160406-100000160459"> </a></td><td>Moist heat</td></tr><tr><td style="white-space:nowrap">100000160460<a name="100000160406-100000160460"> </a></td><td>Chemical</td></tr><tr><td style="white-space:nowrap">100000160461<a name="100000160406-100000160461"> </a></td><td>Gamma irradiation</td></tr><tr><td style="white-space:nowrap">100000160462<a name="100000160406-100000160462"> </a></td><td>Electron beam</td></tr><tr><td style="white-space:nowrap">100000160463<a name="100000160406-100000160463"> </a></td><td>Primary packaging</td></tr><tr><td style="white-space:nowrap">100000160464<a name="100000160406-100000160464"> </a></td><td>Secondary packaging</td></tr><tr><td style="white-space:nowrap">100000160465<a name="100000160406-100000160465"> </a></td><td>Physical Importation</td></tr><tr><td style="white-space:nowrap">100000160466<a name="100000160406-100000160466"> </a></td><td>Storage and/or distribution of medicinal product</td></tr><tr><td style="white-space:nowrap">100000160467<a name="100000160406-100000160467"> </a></td><td>Manufacturer of active substance</td></tr><tr><td style="white-space:nowrap">100000160476<a name="100000160406-100000160476"> </a></td><td>Preparation of Working Cell Bank</td></tr><tr><td style="white-space:nowrap">100000160477<a name="100000160406-100000160477"> </a></td><td>Storage of Master Cell Bank and/or Working Cell Bank</td></tr><tr><td style="white-space:nowrap">100000160478<a name="100000160406-100000160478"> </a></td><td>Bioequivalence Contract Research Organisation (CRO)</td></tr><tr><td style="white-space:nowrap">100000160479<a name="100000160406-100000160479"> </a></td><td>Manufacturer of ancillary medicinal product</td></tr><tr><td style="white-space:nowrap">100000160480<a name="100000160406-100000160480"> </a></td><td>Manufacturer of medical device</td></tr><tr><td style="white-space:nowrap">100000160481<a name="100000160406-100000160481"> </a></td><td>Manufacturer of ancillary substance used in medical device</td></tr><tr><td style="white-space:nowrap">100000160482<a name="100000160406-100000160482"> </a></td><td>Official Medicine Control Laboratory (OMCL)</td></tr><tr><td style="white-space:nowrap">100000160483<a name="100000160406-100000160483"> </a></td><td>Notified Body of medical device</td></tr><tr><td style="white-space:nowrap">100000163618<a name="100000160406-100000163618"> </a></td><td>Processing of non-sterile medicinal product</td></tr><tr><td style="white-space:nowrap">100000163709<a name="100000160406-100000163709"> </a></td><td>Processing of sterile medicinal product - aseptically prepared</td></tr><tr><td style="white-space:nowrap">100000163713<a name="100000160406-100000163713"> </a></td><td>Manufacturer of active substance intermediate by chemical synthesis</td></tr><tr><td style="white-space:nowrap">100000163714<a name="100000160406-100000163714"> </a></td><td>Manufacturer of active substance intermediate using biological processes</td></tr><tr><td style="white-space:nowrap">100000163715<a name="100000160406-100000163715"> </a></td><td>Active substance intermediate physical processing</td></tr><tr><td style="white-space:nowrap">100000163716<a name="100000160406-100000163716"> </a></td><td>Primary Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000163717<a name="100000160406-100000163717"> </a></td><td>Secondary Packaging of active substance</td></tr><tr><td style="white-space:nowrap">100000163737<a name="100000160406-100000163737"> </a></td><td>Processing of sterile medicinal product - terminally sterilised</td></tr><tr><td style="white-space:nowrap">100000163843<a name="100000160406-100000163843"> </a></td><td>Manufacturer of active substance by chemical synthesis</td></tr><tr><td style="white-space:nowrap">100000163844<a name="100000160406-100000163844"> </a></td><td>Extraction of active substance from natural sources</td></tr><tr><td style="white-space:nowrap">100000163845<a name="100000160406-100000163845"> </a></td><td>Manufacturer of active substance using biological processes</td></tr><tr><td style="white-space:nowrap">100000163846<a name="100000160406-100000163846"> </a></td><td>Active substance physical processing</td></tr><tr><td style="white-space:nowrap">200000023301<a name="100000160406-200000023301"> </a></td><td>Importation of intermediate which undergoes further processing</td></tr><tr><td style="white-space:nowrap">200000028596<a name="100000160406-200000028596"> </a></td><td>Manufacturer of active substance starting material using biological processes</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/100000160406"/>
  <version value="1.0.0"/>
  <name value="ManufacturingActivityCs"/>
  <title value="Manufacturing Activity Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-04T16:15:09+01:00"/>
  <publisher value="EMA"/>
  <contact>
    <name value="EMA"/>
    <telecom>
      <system value="url"/>
      <value value="https://support.ema.europa.eu/esc"/>
    </telecom>
  </contact>
  <description value="Manufacturing Activity Value Set"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="50"/>
  <concept>
    <code value="100000160407"/>
    <display value="Manufacturer responsible for batch certification"/>
  </concept>
  <concept>
    <code value="100000160408"/>
    <display value="Quality control testing of medicinal product"/>
  </concept>
  <concept>
    <code value="100000160409"/>
    <display value="Microbiological testing: sterility"/>
  </concept>
  <concept>
    <code value="100000160410"/>
    <display value="Microbiological testing: non-sterility"/>
  </concept>
  <concept>
    <code value="100000160411"/>
    <display value="Chemical/Physical testing"/>
  </concept>
  <concept>
    <code value="100000160412"/>
    <display value="Biological testing"/>
  </concept>
  <concept>
    <code value="100000160413"/>
    <display value="Processing operations for the medicinal product"/>
  </concept>
  <concept>
    <code value="100000160415"/>
    <display value="Manufacturer of solvent / diluent"/>
  </concept>
  <concept>
    <code value="100000160448"/>
    <display value="Quality control testing of active substance"/>
  </concept>
  <concept>
    <code value="100000160449"/>
    <display value="Microbiological testing: sterility"/>
  </concept>
  <concept>
    <code value="100000160450"/>
    <display value="Microbiological testing: non-sterility"/>
  </concept>
  <concept>
    <code value="100000160451"/>
    <display value="Chemical/Physical testing"/>
  </concept>
  <concept>
    <code value="100000160452"/>
    <display value="Biological testing"/>
  </concept>
  <concept>
    <code value="100000160453"/>
    <display value="Manufacturer of active substance intermediate"/>
  </concept>
  <concept>
    <code value="100000160454"/>
    <display value="Packaging of active substance"/>
  </concept>
  <concept>
    <code value="100000160455"/>
    <display value="Storage and/or distribution of active substance"/>
  </concept>
  <concept>
    <code value="100000160456"/>
    <display value="Sterilisation"/>
  </concept>
  <concept>
    <code value="100000160457"/>
    <display value="Filtration"/>
  </concept>
  <concept>
    <code value="100000160458"/>
    <display value="Dry heat"/>
  </concept>
  <concept>
    <code value="100000160459"/>
    <display value="Moist heat"/>
  </concept>
  <concept>
    <code value="100000160460"/>
    <display value="Chemical"/>
  </concept>
  <concept>
    <code value="100000160461"/>
    <display value="Gamma irradiation"/>
  </concept>
  <concept>
    <code value="100000160462"/>
    <display value="Electron beam"/>
  </concept>
  <concept>
    <code value="100000160463"/>
    <display value="Primary packaging"/>
  </concept>
  <concept>
    <code value="100000160464"/>
    <display value="Secondary packaging"/>
  </concept>
  <concept>
    <code value="100000160465"/>
    <display value="Physical Importation"/>
  </concept>
  <concept>
    <code value="100000160466"/>
    <display value="Storage and/or distribution of medicinal product"/>
  </concept>
  <concept>
    <code value="100000160467"/>
    <display value="Manufacturer of active substance"/>
  </concept>
  <concept>
    <code value="100000160476"/>
    <display value="Preparation of Working Cell Bank"/>
  </concept>
  <concept>
    <code value="100000160477"/>
    <display value="Storage of Master Cell Bank and/or Working Cell Bank"/>
  </concept>
  <concept>
    <code value="100000160478"/>
    <display value="Bioequivalence Contract Research Organisation (CRO)"/>
  </concept>
  <concept>
    <code value="100000160479"/>
    <display value="Manufacturer of ancillary medicinal product"/>
  </concept>
  <concept>
    <code value="100000160480"/>
    <display value="Manufacturer of medical device"/>
  </concept>
  <concept>
    <code value="100000160481"/>
    <display
             value="Manufacturer of ancillary substance used in medical device"/>
  </concept>
  <concept>
    <code value="100000160482"/>
    <display value="Official Medicine Control Laboratory (OMCL)"/>
  </concept>
  <concept>
    <code value="100000160483"/>
    <display value="Notified Body of medical device"/>
  </concept>
  <concept>
    <code value="100000163618"/>
    <display value="Processing of non-sterile medicinal product"/>
  </concept>
  <concept>
    <code value="100000163709"/>
    <display
             value="Processing of sterile medicinal product - aseptically prepared"/>
  </concept>
  <concept>
    <code value="100000163713"/>
    <display
             value="Manufacturer of active substance intermediate by chemical synthesis"/>
  </concept>
  <concept>
    <code value="100000163714"/>
    <display
             value="Manufacturer of active substance intermediate using biological processes"/>
  </concept>
  <concept>
    <code value="100000163715"/>
    <display value="Active substance intermediate physical processing"/>
  </concept>
  <concept>
    <code value="100000163716"/>
    <display value="Primary Packaging of active substance"/>
  </concept>
  <concept>
    <code value="100000163717"/>
    <display value="Secondary Packaging of active substance"/>
  </concept>
  <concept>
    <code value="100000163737"/>
    <display
             value="Processing of sterile medicinal product - terminally sterilised"/>
  </concept>
  <concept>
    <code value="100000163843"/>
    <display value="Manufacturer of active substance by chemical synthesis"/>
  </concept>
  <concept>
    <code value="100000163844"/>
    <display value="Extraction of active substance from natural sources"/>
  </concept>
  <concept>
    <code value="100000163845"/>
    <display
             value="Manufacturer of active substance using biological processes"/>
  </concept>
  <concept>
    <code value="100000163846"/>
    <display value="Active substance physical processing"/>
  </concept>
  <concept>
    <code value="200000023301"/>
    <display
             value="Importation of intermediate which undergoes further processing"/>
  </concept>
  <concept>
    <code value="200000028596"/>
    <display
             value="Manufacturer of active substance starting material using biological processes"/>
  </concept>
</CodeSystem>