Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-drug-product-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"/>
<resource>
<Composition>
<!-- comp-drug-components -->
<id value="a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: Composition</b><a name="a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca1694a7b-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 Composition "a1694a7b-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>status</b>: final</p><p><b>type</b>: Product Note - Drug Components <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>date</b>: 2023-10-01</p><p><b>author</b>: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d</p><p><b>title</b>: 3.2.P.2.1.1 - Components of the Drug Product</p></div>
</text>
<status value="final"/>
<type>
<text value="Product Note - Drug Components"/>
</type>
<subject>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subject>
<date value="2023-10-01"/>
<author>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d"/>
</author>
<title value="3.2.P.2.1.1 - Components of the Drug Product"/>
<section>
<title value="3.2.P.2.1.1.1 - Drug Substance"/>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>The compatibility of the drug substance with the excipients listed in 3.2.P.1 should be discussed.
Additionally, key physicochemical characteristics (eg, water content, solubility, particle size
distribution, polymorphic or solid state form) of the drug substance that can influence the
performance of the drug product should be discussed.</p>
<p>For combination products, the compatibility of drug substances with each other should be
discussed.</p>
</div>
</text>
</section>
<section>
<title value="3.2.P.1.1.2 - Excipients"/>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>The choice of excipients listed in 3.2.P.1, their concentration, and the characteristics that can
influence the drug product manufacturability and performance should be discussed relative to
their respective functions.</p>
</div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<resource>
<Composition>
<!-- composition-drug-pq-formulation -->
<id value="a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: Composition</b><a name="a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca1694a7a-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 Composition "a1694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Composition-drug-pq.html">Composition - Drug PQ</a></p></div><p><b>status</b>: final</p><p><b>type</b>: Product Note - Formulation Development <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>date</b>: 2023-10-01</p><p><b>author</b>: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d</p><p><b>title</b>: 3.2.P.2.2.1 - Formulation Development</p></div>
</text>
<status value="final"/>
<type>
<text value="Product Note - Formulation Development"/>
</type>
<subject>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subject>
<date value="2023-10-01"/>
<author>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d"/>
</author>
<title value="3.2.P.2.2.1 - Formulation Development"/>
<section>
<title value="3.2.P.2.2.1.1 - Formulation History"/>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<ul>
<li>Drug product description including difference or similarity between the drug product and reference product, if applicable</li>
<li>Propose route of administration (include any dilution or reconstitution necessary)</li>
<li>Choice of manufacturing process, explain choice if alternative process could have been applicable (e.g. aseptic processing instead of terminal sterilization, direct compression instead of granulation). If different processes were used for different formulation highlight and explain differences, refer at 3.2.P.2.3. If no change in the process occurred refer to 3.3.P.3.3 and avoid duplication data.</li>
</ul>
<p>Table 1 - Formulation history for Stelbatolol</p>
<table>
<tr>
<th>Formulation Identifier</th>
<th>Composition</th>
<th>Change</th>
<th>Development phase</th>
</tr>
<tr>
<td>1233545</td>
<td>Composition 1a</td>
<td>Changes made are listed here</td>
<td>Pre-clinical phase</td>
</tr>
</table>
</div>
</text>
</section>
<section>
<title value="3.2.P.2.2.1.2 - Formulation Development Studies"/>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>Summary of the formulation developmental studies conducted are provided in Table 2</p>
<p>Table 2 - Formulation Development Studies</p>
<table>
<tr>
<th>Study</th>
<th>Formulation identifier </th>
<th>Objective</th>
<th>Quality attribute evaluated</th>
<th>Study design</th>
<th>Study result</th>
</tr>
<tr>
<td>Study Name</td>
<td>12234a</td>
<td>Short description of the study objective</td>
<td>CQA information</td>
<td>Short description of the design</td>
<td>Reference to the table showing study results</td>
</tr>
</table>
</div>
</text>
</section>
<section>
<title
value="3.2.P.2.2.4 - Summary for Risk Assessment of Elemental Impurities in Drug Product"/>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>Summary of the risk assessment for product...</p>
</div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"/>
<resource>
<Composition>
<!-- composition-drug-pq-risk -->
<id value="a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: Composition</b><a name="a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca1694a8a-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 Composition "a1694a8a-aafa-4cbe-8135-c788a9a4d3d5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Composition-drug-pq.html">Composition - Drug PQ</a></p></div><p><b>status</b>: final</p><p><b>type</b>: Product Note - Summary for Risk of Impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>date</b>: 2023-10-01</p><p><b>author</b>: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d</p><p><b>title</b>: 3.2.P.2.2.4 - Summary for Risk of Impurities</p></div>
</text>
<status value="final"/>
<type>
<text value="Product Note - Summary for Risk of Impurities"/>
</type>
<subject>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</subject>
<date value="2023-10-01"/>
<author>
<!-- Organization/organization-drug-pq-ex1 -->
<reference
value="Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d"/>
</author>
<title value="3.2.P.2.2.4 - Summary for Risk of Impurities"/>
<section>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<p>Text for the risk assessment of elemental impurities in the product</p>
</div>
</text>
</section>
</Composition>
</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-pq-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 "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>comprisedOf</b>: See on this page: ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44</p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td></tr><tr><td style="display: none">*</td><td>Stalbatolol</td></tr></table><blockquote><p><b>characteristic</b></p><p><b>type</b>: Physicochemical properties <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#physicochemical)</span></p><p><b>value</b>: Product properties with cross reference to other dossier sections as 3.2.P.5.1 Consider parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity. Any properties which are not included in the product specification, with explanation of parameter control and relevant studies. If applicable refer to relevant compendia monograph <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>characteristic</b></p><p><b>type</b>: pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#pH)</span></p><p><b>value</b>: 7.0</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>type</b>: Ionic Strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#ionic-strength)</span></p><p><b>value</b>: 23 mg/mL</p></blockquote></div>
</text>
<comprisedOf>
<!-- ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex2 -->
<reference
value="ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44"/>
</comprisedOf>
<name>
<productName value="Stalbatolol"/>
</name>
<characteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="physicochemical"/>
<display value="Physicochemical properties"/>
</coding>
</type>
<valueCodeableConcept>
<text
value="Product properties with cross reference to other dossier sections as 3.2.P.5.1 Consider parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity. Any properties which are not included in the product specification, with explanation of parameter control and relevant studies. If applicable refer to relevant compendia monograph"/>
</valueCodeableConcept>
</characteristic>
<characteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="pH"/>
<display value="pH"/>
</coding>
</type>
<valueQuantity>
<value value="7.0"/>
</valueQuantity>
</characteristic>
<characteristic>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="ionic-strength"/>
<display value="Ionic Strength"/>
</coding>
</type>
<valueQuantity>
<value value="23"/>
<unit value="mg/mL"/>
</valueQuantity>
</characteristic>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:1531c777-50c3-047d-2798-de3d001d2c44"/>
<resource>
<ManufacturedItemDefinition>
<!-- manufactureditemdefinition-drug-pq-ex2 -->
<id value="1531c777-50c3-047d-2798-de3d001d2c44"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_1531c777-50c3-047d-2798-de3d001d2c44"> </a><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="1531c777-50c3-047d-2798-de3d001d2c44"> </a><a name="hc1531c777-50c3-047d-2798-de3d001d2c44"> </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 ManufacturedItemDefinition "1531c777-50c3-047d-2798-de3d001d2c44" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ManufacturedItemDefinition-drug-pq.html">ManufacturedItemDefinition - Drug PQ</a></p></div><p><b>status</b>: active</p><p><b>name</b>: Stelbatolol 5mg tablet</p><p><b>manufacturedDoseForm</b>: <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>property</b></p><p><b>type</b>: Overage by mass (%) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufactured-item-property-pq-example.html">Manufactured Item Property - example</a>#overage-by-mass)</span></p><p><b>value</b>: 5 %</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Overage reason <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufactured-item-property-pq-example.html">Manufactured Item Property - example</a>#overage-reason)</span></p><p><b>value</b>: Overage is necessary because... <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
</text>
<status value="active"/>
<name value="Stelbatolol 5mg tablet"/>
<manufacturedDoseForm>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
</manufacturedDoseForm>
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufactured-item-property-pq-example"/>
<code value="overage-by-mass"/>
<display value="Overage by mass (%)"/>
</coding>
</type>
<valueQuantity>
<value value="5"/>
<unit value="%"/>
</valueQuantity>
</property>
<!-- this and the above could also be extensions -->
<property>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufactured-item-property-pq-example"/>
<code value="overage-reason"/>
<display value="Overage reason"/>
</coding>
</type>
<valueCodeableConcept>
<text value="Overage is necessary because..."/>
</valueCodeableConcept>
</property>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d"/>
<resource>
<Organization>
<!-- organization-drug-pq-ex1 -->
<id value="9fe98cfa-9246-8313-0fc5-d15e613b5d6d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_9fe98cfa-9246-8313-0fc5-d15e613b5d6d"> </a><p><b>Generated Narrative: Organization</b><a name="9fe98cfa-9246-8313-0fc5-d15e613b5d6d"> </a><a name="hc9fe98cfa-9246-8313-0fc5-d15e613b5d6d"> </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 "9fe98cfa-9246-8313-0fc5-d15e613b5d6d" </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p></div>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3003040516"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
<code value="drug-substance-manufacture"/>
<display value="Drug Substance Manufacture"/>
</coding>
</type>
<name value="AAA Molybdenum Products, Inc."/>
</Organization>
</resource>
</entry>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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