Pharmaceutical Quality (Industry)
1.0.0 - STU1

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>