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
<Observation xmlns="http://hl7.org/fhir">
<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>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="observation-test-result-longterm25c-initial-1"> </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 Observation "observation-test-result-longterm25c-initial-1" </p><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">ActivityDefinition/activitydefinition-test-drug-pq-ex1</a></p><p><b>status</b>: final</p><p><b>code</b>: Test Components - Long-term 25C etc - Initial (XYZ) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>subject</b>: <a href="Medication-medication-batch-information-drug-pq-ex1.html">Medication/medication-batch-information-drug-pq-ex1</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/organization-drug-pq-ex1</a> "AAA Molybdenum Products, Inc."</p><p><b>specimen</b>: <a href="Specimen-specimen-drug-pq-ex1.html">Specimen/specimen-drug-pq-ex1</a></p><p><b>hasMember</b>: </p><ul><li><a href="Observation-observation-test-result-lt25c-i1-description.html">Observation/observation-test-result-lt25c-i1-description</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp1.html">Observation/observation-test-result-lt25c-i1-degradation-imp1</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp2.html">Observation/observation-test-result-lt25c-i1-degradation-imp2</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp3.html">Observation/observation-test-result-lt25c-i1-degradation-imp3</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-unspecified.html">Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified</a></li><li><a href="Observation-observation-test-result-lt25c-i1-degradation-imp-total.html">Observation/observation-test-result-lt25c-i1-degradation-imp-total</a></li><li><a href="Observation-observation-test-result-lt25c-i1-water.html">Observation/observation-test-result-lt25c-i1-water</a></li><li><a href="Observation-observation-test-result-lt25c-i1-microbiological.html">Observation/observation-test-result-lt25c-i1-microbiological</a></li><li><a href="Observation-observation-test-result-lt25c-i1-uniformity.html">Observation/observation-test-result-lt25c-i1-uniformity</a></li></ul></div>
</text>
<!-- <contained>
<Observation>
<id value="observation-test-result-lt25c-i1-description"/>
<instantiatesReference>
<!-\-ObservationDefinition/Description-\->
<reference value="ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="XXX"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<!-\-id value="LongTerm25C-initial-1-Degradation-imp1"/-\->
<id value="observation-test-result-drug-pq-ex1"/>
<meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
<instantiatesReference>
<!-\-ObservationDefinition/Degradation-\->
<reference value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.101"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<!-\- could have the code of an impurity substance, or could have an extension to point to it as a resource -\->
<text value="Impurity 1"/>
</valueCodeableConcept>
</component>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-imp2"/>
<instantiatesReference>
<!-\-ObservationDefinition/Degradation-\->
<reference value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.201"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 2"/>
</valueCodeableConcept>
</component>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-imp3"/>
<instantiatesReference>
<!-\-ObservationDefinition/Degradation-\->
<reference value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.201"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Impurity 3"/>
</valueCodeableConcept>
</component>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-impUnspecified"/>
<instantiatesReference>
<!-\-ObservationDefinition/Degradation-\->
<reference value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.101"/>
<comparator value="<"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Any Unspecified Degradation Impurity"/>
</valueCodeableConcept>
</component>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Degradation-impTotal"/>
<instantiatesReference>
<!-\-ObservationDefinition/Degradation-\->
<reference value="ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="DGP"/>
<display value="Degradation Products"/>
</coding>
<text value="Degradation Products"/>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.801"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
<component>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
<valueCodeableConcept>
<text value="Total Degradation Impurities"/>
</valueCodeableConcept>
</component>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Water"/>
<instantiatesReference>
<!-\-ObservationDefinition/observationdefinition-simple-pq-ex1-\->
<reference value="ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="WWW"/>
<display value="Water Content"/>
</coding>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueQuantity>
<value value="0.1501"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Microbiological"/>
<instantiatesReference>
<!-\-ObservationDefinition/Microbiological-\->
<reference value="ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="YYY"/>
<display value="Microbiological Quality"/>
</coding>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained> -->
<!-- <contained>
<Observation>
<id value="LongTerm25C-initial-1-Uniformity"/>
<instantiatesReference>
<!-\-ObservationDefinition/Uniformity-\->
<reference value="ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8"/>
</instantiatesReference>
<status value="final"/>
<code>
<coding>
<system value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="ZZZ"/>
<display value="Uniformity of dosage units (by weight)"/>
</coding>
</code>
<subject>
<!-\-Medication/medication-batch-information-drug-pq-ex1-\->
<reference value="Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c"/>
</subject>
<effectiveDateTime value="2023-01-01T12:00:00Z"/>
<performer>
<!-\-Organization/tester-\->
<reference value="Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9"/>
</performer>
<valueCodeableConcept>
<text value="Complies"/>
</valueCodeableConcept>
</Observation>
</contained> -->
<extension
url="http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy">
<valueReference>🔗
<!-- ActivityDefinition/activityLongTerm25XYZ-Initial -->
<!-- <reference value="ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"/> -->
<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>
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
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