Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<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"><p><b>Generated Narrative: DiagnosticReport</b><a name="microbiologicalReport"> </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 "microbiologicalReport" </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-cs-reportType-local-pq.html">CodeSystem - Report Type</a>#Microbiological Attributes Report)</span></p><p><b>subject</b>: <a href="#Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51">See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)</a></p><p><b>effective</b>: 2020-12</p><p><b>result</b>: <a href="#Observation_18c2d9e0-08c7-84e2-5e59-8f56321f895d">See above (Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d)</a></p></div>
</text>
<status value="final"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq"/>
<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 <1111> </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 <61> and
<62>,</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 <61> and <62>.
All lots met the USP <1111> 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 <921> </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"/>
<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"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-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 "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </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-local-pq.html">CodeSystem - Product Name Type</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-local-pq"/>
<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"><p><b>Generated Narrative: Medication</b><a name="339b69fd-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 "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </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"><p><b>Generated Narrative: Organization</b><a name="378fbe5f-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 "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>
</text>
<name value="Testing Lab"/>
</Organization>
</resource>
</entry>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change