Pharmaceutical Quality (Industry)
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Pharmaceutical Quality (Industry), 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/uv-dx-pq/ and changes regularly. See the Directory of published versions

: Example: Bundle – Product Microbiological Attributes - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <!--  Product  Microbiological Attributes  -->
  <id value="bundle-drug-product-microbiological-attributes-pq-ex1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-microbiological-attributes-pq"/>
  </meta>
  <type value="collection"/>
  <!--  Diagnostic report doesn't carry much extra value but does collect all the observations  -->
  <entry>
    <fullUrl value="urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd"/>
    <resource>
      <DiagnosticReport>
        <id value="microbiologicalReport"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DiagnosticReport_microbiologicalReport"> </a><p><b>Generated Narrative: DiagnosticReport</b><a name="microbiologicalReport"> </a><a name="hcmicrobiologicalReport"> </a></p><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">Resource DiagnosticReport &quot;microbiologicalReport&quot; </p></div><p><b>status</b>: final</p><p><b>code</b>: Microbiological Attributes Report <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-report-type.html">Pharmaceutical Report Type Codes</a>#Microbiological Attributes Report)</span></p><p><b>subject</b>: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51</p><p><b>effective</b>: 2020-12</p><p><b>result</b>: See on this page: Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d</p></div>
        </text>
        <status value="final"/>
        <code>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"/>
            <code value="Microbiological Attributes Report"/>
            <display value="Microbiological Attributes Report"/>
          </coding>
        </code>
        <subject>
          <!-- Medication/medication-actual-batch -->
          <reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
        </subject>
        <effectiveDateTime value="2020-12"/>
        <!--  start of stability test  -->
        <result>
          <!-- Observation/observationDescription -->
          <reference
                     value="Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d"/>
        </result>
      </DiagnosticReport>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:18c2d9e0-08c7-84e2-5e59-8f56321f895d"/>
    <resource>
      <Observation>
        <!-- observationDescription -->
        <id value="18c2d9e0-08c7-84e2-5e59-8f56321f895d"/>
        <text>
          <status value="additional"/>
          <div xmlns="http://www.w3.org/1999/xhtml">
                  <div style="font-family: 'Times New Roman', Times, serif;">
                     <p>
                        <span>The microbiological attributes of the excipients were
                                    characterized during the development program. All excipients
                                    meet USP &lt;1111&gt; </span>
                        <i>
                           <span>Microbial Examination of
                                        Nonsterile Products:</span>
                        </i>
                        <span> </span>
                        <i>
                           <span>Acceptance Criteria for Pharmaceutical
                                        Preparations and Substances for Pharmaceutical
                                    Use</span>
                        </i>
                        <span> </span>
                        <span>and Ph. Eur. 5.1.4
                                        </span>
                        <i>
                           <span>Microbiological quality of non-sterile
                                        pharmaceutical preparations and substances for
                                        pharmaceutical use</span>
                        </i>
                        <i>
                           <span>,</span>
                        </i>
                        <span>
                                    when tested in accordance with USP &lt;61&gt; and
                                    &lt;62&gt;,</span>
                        <span> </span>
                        <span>and Ph. Eur. 2.6.12 and
                                    2.6.13, where applicable.</span>
                     </p>
                     <p>
                        <span>Current Good Manufacturing Practices are used which minimize
                                    the possibility for microbial contamination for the finished
                                    product. This was confirmed via testing of three lots
                                    manufactured at the commercial scale for the purpose of PPQ and
                                    stability studies according to USP &lt;61&gt; and &lt;62&gt;.
                                    All lots met the USP &lt;1111&gt; criteria for nonaqueous
                                    preparations for oral use (Total Aerobic Microbial Count NMT
                                        10<sup>3</sup> CFU/gram, Total Combined Yeast and Mold Count
                                    NMT 10<sup>2</sup> CFU/gram and absence of
                                        </span>
                        <i>
                           <span>Escherichia coli </span>
                        </i>
                        <span>in 1
                                    gram), as stated in Sections 3.2.P.5.4 and 3.2.P.8.3.</span>
                     </p>
                     <p>
                        <span>Per USP &lt;921&gt; </span>
                        <i>
                           <span>Water
                                    Determination</span>
                        </i>
                        <span>, the drug product specification
                                    is set to NMT 1.0% at release and NMT 2.0% for shelf life as
                                    described in Section 3.2.P.5.1. The water activity for the drug
                                    product was confirmed to comply with the specifications as
                                    stated in Sections 3.2.P.5.4 and 3.2.P.8.3. </span>
                     </p>
                     <p>
                        <span>A product microbial risk evaluation conducted for the drug
                                    product manufacturing site supports annual microbiological
                                    quality testing at release and on stability following the
                                    specification listed in Section 3.2.P.5.1. Input material,
                                    manufacturing, process controls as well as environmental
                                    controls are all in place to ensure consistent microbiological
                                    quality. The excipients used in the manufacture of the product
                                    are tested for microbiological quality as required by their
                                    respective compendial requirements. This product demonstrates
                                    satisfactory microbiological quality based on the results of all
                                    batches evaluated. Microbiological quality testing will continue
                                    to be monitored annually on the drug product for release and
                                    throughout the stability study.</span>
                     </p>
                  </div>
               </div>
        </text>
        <status value="final"/>
        <code>
          <coding>
            <system
                    value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
            <code value="DESC"/>
            <display value="Description"/>
          </coding>
          <text value="Description"/>
        </code>
        <subject>
          <!-- Medication/medication-actual-batch -->
          <reference value="Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
        </subject>
        <effectiveDateTime value="2023-01-01T12:00:00Z"/>
        <performer>
          <!-- Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 -->
          <reference
                     value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"/>
        </performer>
        <valueCodeableConcept>
          <text value="Complies"/>
        </valueCodeableConcept>
      </Observation>
    </resource>
  </entry>
  <!--  MedicinalProductDefinition - the main resource in any product scenario  -->
  <entry>
    <fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
    <!--  Section 1.1 - DP Identification  -->
    <resource>
      <MedicinalProductDefinition>
        <!-- medicinalproductdefinition-drug-product-dxpq-ex1 -->
        <id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a></p><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">Resource MedicinalProductDefinition &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d5&quot; </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-productNameType-pq-example.html">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>20mg</td><td>Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>
        </text>
        <description value="Textual description of the product"/>
        <combinedPharmaceuticalDoseForm>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="10225000"/>
            <display value="Gastro-resistant tablet"/>
          </coding>
        </combinedPharmaceuticalDoseForm>
        <route>
          <coding>
            <system value="http://standardterms.edqm.eu"/>
            <code value="20053000"/>
            <display value="Oral use"/>
          </coding>
        </route>
        <name>
          <productName value="Stelbat Tablets, 20mg"/>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"/>
              <code value="Proprietary"/>
              <display value="Proprietary"/>
            </coding>
          </type>
          <part>
            <part value="20mg"/>
            <type>
              <coding>
                <system
                        value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
                <code value="StrengthPart"/>
                <display value="Strength part"/>
              </coding>
            </type>
          </part>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <!--  Section 8 - Batch or Lot Information (batch 1 of 3)  -->
  <entry>
    <fullUrl value="urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
    <resource>
      <Medication>
        <!-- medication-actual-batch -->
        <id value="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </a><p><b>Generated Narrative: Medication</b><a name="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </a><a name="hc339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"> </a></p><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">Resource Medication &quot;339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51&quot; </p></div><p><b>code</b>:  <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></div>
        </text>
        <code>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
            <valueReference>
              <!--  todo consider change this be the MID?  -->
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </valueReference>
          </extension>
        </code>
      </Medication>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08"/>
    <resource>
      <Organization>
        <!-- testing lab -->
        <!-- 378fbe5f-5926-3a5c-4c64-5428df877b08 -->
        <id value="378fbe5f-5926-3a5c-4c64-5428df877b08"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_378fbe5f-5926-3a5c-4c64-5428df877b08"> </a><p><b>Generated Narrative: Organization</b><a name="378fbe5f-5926-3a5c-4c64-5428df877b08"> </a><a name="hc378fbe5f-5926-3a5c-4c64-5428df877b08"> </a></p><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">Resource Organization &quot;378fbe5f-5926-3a5c-4c64-5428df877b08&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3007270600</p><p><b>active</b>: true</p><p><b>type</b>: Analytical Testing - Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#analytical-testing-release)</span></p><p><b>name</b>: Testing Lab</p></div>
        </text>
        <identifier>
          <system value="urn:oid:2.16.840.1.113883.4.82"/>
          <value value="3007270600"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
            <code value="analytical-testing-release"/>
            <display value="Analytical Testing - Release"/>
          </coding>
        </type>
        <name value="Testing Lab"/>
      </Organization>
    </resource>
  </entry>
</Bundle>