Generated Narrative: Substance substance-drug-pq-ex1

Medication Manufacturing Batch

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT1

instance: false

Codes

-Concept
*Substance

Generated Narrative: SpecimenDefinition specimendefinition-drug-pq-ex1

status: Active

typeTested

preference: Preferred

Handlings

-Instruction
*

25°C/60% RH

Generated Narrative: Substance substance-drug-pq-ex1

Medication Manufacturing Batch

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT1

instance: false

Codes

-Concept
*Substance

Generated Narrative: Specimen specimen-drug-pq-ex1

Collections

-Collected[x]
*2020-12-01

processing

description: No storage

processing

description: 25°C/60% RH
Metadata
Title Stability Monitoring Program
Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use
Description

Narrative description of Stability Study
Type Stability Study Protocol
PlanDefinition Action
Title Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg
PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg)
Title Long-Term
Description

25°C/60% RH
PlanDefinition Sub-Action (Parent Action Title: Long-Term)
Title Initial
Timing Once
PlanDefinition Sub-Action (Parent Action Title: Initial)
Title XYZ
Definition http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
Generated using version 0.5.4 of the sample-content-ig Liquid templates
<type> <coding> <system value="http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/> <code value="1244588"/> <display value="Stability Study Protocol"/> </coding> </type> <status value="active"/> <subjectReference> <reference value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/> </subjectReference> <description value="Narrative description of Stability Study"/> <action> <title value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg"/> <action> <title value="Long-Term"/> <description value="25°C/60% RH"/> <action> <title value="Initial"/> <timingTiming> <repeat> <boundsRange> <low> <value value="0"/> <unit value="months"/> <system value="http://unitsofmeasure.org"/> <code value="mo"/> </low> <high> <value value="0"/> <unit value="months"/> <system value="http://unitsofmeasure.org"/> <code value="mo"/> </high> </boundsRange> <frequency value="1"/> </repeat> </timingTiming> <action> <title value="XYZ"/> <definitionCanonical value="http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/> </action> </action> </action> </action> </PlanDefinition> </resource> </entry> <entry> <fullUrl value="http://example.com/ActivityDefinition/activitydefinition-test-drug-pq-ex1"/> <resource> <ActivityDefinition> <id value="activitydefinition-test-drug-pq-ex1"/> <meta> <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq"/> </meta> <language value="en"/> <text> <status value="extensions"/><div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_activitydefinition-test-drug-pq-ex1"> </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">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</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> <url value="http://example-server.com/fhir/ActivityDefinition/activitydefinition-test-drug-pq-ex1"/> <title value="Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ."/> <status value="active"/> </ActivityDefinition> </resource> </entry> <entry> <fullUrl value="http://example.com/ObservationDefinition/accelerated40X"/> <resource> <ObservationDefinition> <id value="accelerated40X"/> <meta> <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/> </meta> <language value="en"/> <text> <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_accelerated40X"> </a><p class="res-header-id"><b>Generated Narrative: ObservationDefinition accelerated40X</b></p><a name="accelerated40X"> </a><a name="hcaccelerated40X"> </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-ObservationDefinition-test-method-drug-pq.html">ObservationDefinition - Test Method PQ</a></p></div><p><b>status</b>: Active</p><p><b>code</b>: <span title="Codes:">Battery of tests 'X' at 40°C/75% RH</span></p></div> </text> <status value="active"/> <code> <text value="Battery of tests 'X' at 40°C/75% RH"/> </code> </ObservationDefinition> </resource> </entry> <entry> <fullUrl value="http://example.com/DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod"/> <resource> <DiagnosticReport> <id value="diagnosticreport-analysis-drug-pq-stability-prod"/> <meta> <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq"/> </meta> <language value="en"/> <text> <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><a name="DiagnosticReport_diagnosticreport-analysis-drug-pq-stability-prod"> </a><p class="res-header-id"><b>Generated Narrative: DiagnosticReport diagnosticreport-analysis-drug-pq-stability-prod</b></p><a name="diagnosticreport-analysis-drug-pq-stability-prod"> </a><a name="hcdiagnosticreport-analysis-drug-pq-stability-prod"> </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-DiagnosticReport-analysis-drug-pq.html">DiagnosticReport - Analysis Drug PQ</a></p></div><h2><span title="Codes:{http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type Stability Study Report - 18 months}">Stability Study Report - 18 months</span> </h2><table class="grid"><tr><td>When For</td><td>2020-12</td></tr><tr><td>Performer</td><td> <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></td></tr><tr><td>Identifier</td><td> <code>https://eudract.europa.eu/example/identifier</code>/ABC1234</td></tr></table><p><b>Report Details</b></p><table class="grid"><tr><td><b>Code</b></td><td><b>Value</b></td><td><b>Flags</b></td><td><b>When For</b></td></tr><tr><td><a href="Observation-observation-test-result-longterm25c-initial-1.html"><span title="Codes:">Test Components - Long-term 25C etc - Initial (XYZ)</span></a></td><td/><td>Final</td><td>2023-01-01 12:00:00+0000</td></tr></table><div><p>The samples have been assessed for initial period; no shelf life determined.</p> </div></div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"> <valueReference> <reference value="PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/> </valueReference> </extension> <extension url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq"> <valueCodeableConcept> <text value="information about statistical model utilized to interpret stability study results"/> </valueCodeableConcept> </extension> <extension url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq"> <valueCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/container-orientation"/> <code value="horizontal"/> <display value="horizontal"/> </coding> <text value="Horizontal"/> </valueCodeableConcept> </extension> <identifier> <system value="https://eudract.europa.eu/example/identifier"/> <value value="ABC1234"/> </identifier> <status value="final"/> <code> <coding> <system value="http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type"/> <code value="Stability Study Report - 18 months"/> <display value="Stability Study Report - 18 months"/> </coding> </code> <effectiveDateTime value="2020-12"> <extension url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq"> <valueCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/time-point-description"/> <code value="Delayed Start Code"/> <display value="Delayed Start Code"/> </coding> <text value="Refrigerated delayed testing"/> </valueCodeableConcept> </extension> </effectiveDateTime> <performer> <reference value="Organization/organization-drug-pq-ex1"/> </performer> <result> <reference value="Observation/observation-test-result-longterm25c-initial-1"/> </result> <conclusion value="The samples have been assessed for initial period; no shelf life determined."/> </DiagnosticReport> </resource> </entry> <entry> <fullUrl value="http://example.com/Observation/observation-test-result-longterm25c-initial-1"/> <resource> <Observation> <id value="observation-test-result-longterm25c-initial-1"/> <meta> <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/> </meta> <language value="en"/> <text> <status value="extensions"/><div xmlns="http://www.w3.org/1999/xhtml"><a name="Observation_observation-test-result-longterm25c-initial-1"> </a><p class="res-header-id"><b>Generated Narrative: Observation observation-test-result-longterm25c-initial-1</b></p><a name="observation-test-result-longterm25c-initial-1"> </a><a name="hcobservation-test-result-longterm25c-initial-1"> </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-Observation-test-result-drug-pq.html">Observation - Test Result Drug PQ</a></p></div><p><b>Triggered by</b>: <a href="ActivityDefinition-activitydefinition-test-drug-pq-ex1.html">Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.</a></p><p><b>status</b>: Final</p><p><b>code</b>: <span title="Codes:">Test Components - Long-term 25C etc - Initial (XYZ)</span></p><p><b>subject</b>: <a href="Medication-medication-batch-information-drug-pq-ex1.html">Medication </a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href="Organization-organization-drug-pq-ex1.html">Organization AAA Molybdenum Products, Inc.</a></p><p><b>specimen</b>: <a href="Specimen-specimen-drug-pq-ex1.html">Specimen</a></p><p><b>hasMember</b>: </p><ul><li><a href="Observation-observation-test-result-lt25c-i1-description.html">Observation Description</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp1.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp2.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp3.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-unspecified.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-total.html">Observation Degradation Products</a></li><li><a href="Observation-observation-test-result-lt25c-i1-water.html">Observation Water Content</a></li><li><a href="Observation-observation-test-result-lt25c-i1-microbiological.html">Observation Microbiological Quality</a></li><li><a href="Observation-observation-test-result-lt25c-i1-uniformity.html">Observation Uniformity of dosage units (by weight)</a></li></ul></div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy"> <valueReference> <reference value="ActivityDefinition/activitydefinition-test-drug-pq-ex1"/> </valueReference> </extension> <status value="final"/> <code> <text value="Test Components - Long-term 25C etc - Initial (XYZ)"/> </code> <subject> <reference value="Medication/medication-batch-information-drug-pq-ex1"/> </subject> <effectiveDateTime value="2023-01-01T12:00:00Z"/> <performer> <reference value="Organization/organization-drug-pq-ex1"/> </performer> <specimen> <reference value="Specimen/specimen-drug-pq-ex1"/> </specimen> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-description"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-degradation-imp1"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-degradation-imp2"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-degradation-imp3"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-degradation-imp-total"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-water"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-microbiological"/> </hasMember> <hasMember> <reference value="Observation/observation-test-result-lt25c-i1-uniformity"/> </hasMember> </Observation> </resource> </entry> <entry> <fullUrl value="http://example.com/Organization/organization-drug-pq-ex1"/> <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> <entry> <fullUrl value="http://example.com/Organization/organization-drug-pq-ex1"/> <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><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> <entry> <fullUrl value="http://example.com/Organization/organization-drug-pq-ex1"/> <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><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>