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-product-manufacturing-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq"/>
</meta>
<language value="en"/>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:55555555-5555-5555-5555-555555555555"/>
<resource>
<MedicinalProductDefinition>
<id value="medicinalproductdefinition-drug-product-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_medicinalproductdefinition-drug-product-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition medicinalproductdefinition-drug-product-pq-ex1</b></p><a name="medicinalproductdefinition-drug-product-pq-ex1"> </a><a name="hcmedicinalproductdefinition-drug-product-pq-ex1"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-MedicinalProductDefinition-drug-product-pq.html">MedicinalProductDefinition - Drug Product PQ</a></p></div><p><b>identifier</b>: <code>http://example.org/identifiers/product</code>/PROD-12345</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://standardterms.edqm.eu 10219000}">Tablet</span></p><p><b>route</b>: <span title="Codes:{http://standardterms.edqm.eu 20053000}">Oral use</span></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ProductName</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol 10mg Tablets</td><td><span title="Codes:{http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq INV}">Invented Name</span></td></tr></table></div>
</text>
<identifier>
<system value="http://example.org/identifiers/product"/>
<value value="PROD-12345"/>
</identifier>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10219000"/>
<display value="Tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbatolol 10mg Tablets"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-product-name-type-pq"/>
<code value="INV"/>
<display value="Invented Name"/>
</coding>
</type>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:66666666-6666-6666-6666-666666666666"/>
<resource>
<SubstanceDefinition>
<id value="substancedefinition-component-substance-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_substancedefinition-component-substance-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition substancedefinition-component-substance-drug-pq-ex1</b></p><a name="substancedefinition-component-substance-drug-pq-ex1"> </a><a name="hcsubstancedefinition-component-substance-drug-pq-ex1"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html">SubstanceDefinition - Component Substance Drug PQ</a></p></div><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>manufacturer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol Hydrochloride</td></tr></table></div>
</text>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<manufacturer>🔗
<reference value="Organization/organization-drug-pq-ex1"/>
</manufacturer>
<name>
<name value="Stelbatolol Hydrochloride"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:77777777-7777-7777-7777-777777777777"/>
<resource>
<PlanDefinition>
<id value="plandefinition-drug-pq-ex4-mnf-process"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_plandefinition-drug-pq-ex4-mnf-process"> </a>
<table class="narrative-table">
<tbody>
<tr>
<th colspan="2" scope="row" class="row-header">Metadata</th>
</tr>
<tr>
<th scope="row" class="row-header">Title</th>
<td class="content-container">Process 1.0</td>
</tr>
<tr>
<th scope="row" class="row-header">Subject Type</th>
<td class="content-container"><a href="MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html">MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use</a></td>
</tr>
<tr>
<th scope="row" class="row-header">Type</th>
<td class="content-container">
Manufacturing Process
</td>
</tr>
<tr>
<th colspan="2" scope="row" class="row-header">Generated using version 0.5.4 of the sample-content-ig Liquid templates</th>
</tr>
</tbody>
</table>
</div>
</text>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq">
<valueMarkdown value="Process has no history recorded yet"/>
</extension>
<url
value="http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex4-mnf-process"/>
<title value="Process 1.0"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
<code value="1244566"/>
<display value="Manufacturing Process"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:88888888-8888-8888-8888-888888888888"/>
<resource>
<DeviceDefinition>
<id value="devicedefinition-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_devicedefinition-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: DeviceDefinition devicedefinition-drug-pq-ex1</b></p><a name="devicedefinition-drug-pq-ex1"> </a><a name="hcdevicedefinition-drug-pq-ex1"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DeviceDefinition-drug-pq.html">DeviceDefinition - Drug PQ</a></p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Rotating Impeller with 1.5mm screen</td><td>Registered name</td></tr></table><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/device-property Maximum Speed}">Maximum Speed</span></td><td>5000 RPM</td></tr></table></div>
</text>
<deviceName>
<name value="Rotating Impeller with 1.5mm screen"/>
<type value="registered-name"/>
</deviceName>
<property>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/device-property"/>
<code value="Maximum Speed"/>
<display value="Maximum Speed"/>
</coding>
</type>
<valueQuantity>
<value value="5000"/>
<unit value="RPM"/>
</valueQuantity>
</property>
</DeviceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:99999999-9999-9999-9999-999999999999"/>
<resource>
<DocumentReference>
<id value="documentreference-drug-pq-process-flow-diagram"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_documentreference-drug-pq-process-flow-diagram"> </a><p class="res-header-id"><b>Generated Narrative: DocumentReference documentreference-drug-pq-process-flow-diagram</b></p><a name="documentreference-drug-pq-process-flow-diagram"> </a><a name="hcdocumentreference-drug-pq-process-flow-diagram"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DocumentReference-drug-pq.html">DocumentReference - Drug PQ</a></p></div><p><b>identifier</b>: <code>http://example.org/fhir/identifier/document</code>/FLOW-001</p><p><b>status</b>: Current</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/diagram-type ProcessFlowDiagram}">Process Flow Diagram</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 11,784 base64 chars)</td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://example.org/fhir/identifier/document"/>
<value value="FLOW-001"/>
</identifier>
<status value="current"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/diagram-type"/>
<code value="ProcessFlowDiagram"/>
<display value="Process Flow Diagram"/>
</coding>
</type>
<content>
<attachment>
<contentType value="image/x-png"/>
<data
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</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:00000000-0000-0000-0000-000000000000"/>
<resource>
<Organization>
<id value="organization-drug-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_organization-drug-pq-ex1"> </a><p class="res-header-id"><b>Generated Narrative: Organization organization-drug-pq-ex1</b></p><a name="organization-drug-pq-ex1"> </a><a name="hcorganization-drug-pq-ex1"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-Organization-drug-pq.html">Organization - Drug PQ</a></p></div><p><b>identifier</b>: <a href="http://terminology.hl7.org/7.1.0/NamingSystem-FEI.html" title=""A FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system generated number used to identify a firm. FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI which is used to identify the firm. The remaining FEIs become children of the surviving FEI and are not used to identify the firm."
For more information, see [https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq](https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=common.faq).">FDA Establishment Identifier</a>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type drug-substance-manufacture}">Drug Substance Manufacture</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
</text>
<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."/>
<contact>
<address>
<line value="7233 W 116th Pl"/>
<line value="Ste C"/>
<city value="Broomfield"/>
<state value="Colorado"/>
<postalCode value="80020"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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