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
<!-- Substance Specification -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-drug-substance-specification-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<resource>
<PlanDefinition>
<id value="specificationProtocol"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_specificationProtocol"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="specificationProtocol"> </a><a name="hcspecificationProtocol"> </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 PlanDefinition "specificationProtocol" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION FOR DRUG SUBSTANCE</p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb</p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification for Drug Substance</p><p><b>code</b>: Overall set of actions <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9">http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3">http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a">http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121">http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17">http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d">http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce">http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d">http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</a></td></tr><tr><td style="display: none">*</td><td>Test <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td><a href="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f">http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</a></td></tr></table></blockquote></div>
</text>
<!-- http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a -->
<url
value="http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a"/>
<title value="SPECIFICATION FOR DRUG SUBSTANCE"/>
<status value="active"/>
<subjectReference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
</subjectReference>
<description value="Narrative description of specifications"/>
<action>
<!-- this is then entire thing -->
<title value="Specification for Drug Substance"/>
<code>
<text value="Overall set of actions"/>
</code>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Description -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Identification -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Assay -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Impurities -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Mutagenic -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Enantiomeric -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Solvents -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Water -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
</action>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/Particles -->
<definitionCanonical
value="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"/>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9"/>
<resource>
<ObservationDefinition>
<!-- Description -->
<id value="52176085-1f30-0c67-9ad7-523c486c82c9"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_52176085-1f30-0c67-9ad7-523c486c82c9"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="52176085-1f30-0c67-9ad7-523c486c82c9"> </a><a name="hc52176085-1f30-0c67-9ad7-523c486c82c9"> </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 ObservationDefinition "52176085-1f30-0c67-9ad7-523c486c82c9" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <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>#DESC)</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"/>
<title value="Description"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="DESC"/>
<display value="Description"/>
</coding>
<text value="Description"/>
</code>
<method>
<text value="Visual inspection"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="A white to brown powder"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b50d892c-8980-0774-39d4-d449732873a3"/>
<resource>
<ObservationDefinition>
<!-- Identification -->
<id value="b50d892c-8980-0774-39d4-d449732873a3"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_b50d892c-8980-0774-39d4-d449732873a3"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="b50d892c-8980-0774-39d4-d449732873a3"> </a><a name="hcb50d892c-8980-0774-39d4-d449732873a3"> </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 ObservationDefinition "b50d892c-8980-0774-39d4-d449732873a3" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <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>#IDT)</span></p><p><b>method</b>: Identification by IR spectroscopy Identification by HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"/>
<title value="Identification"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IDT"/>
<display value="Identification"/>
</coding>
<text value="Identification"/>
</code>
<method>
<text
value="Identification by IR spectroscopy Identification by HPLC"/>
</method>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString value="Conforms with reference"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a"/>
<resource>
<ObservationDefinition>
<!-- Assay -->
<id value="d460b561-110c-7eb6-5d69-788abcca391a"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_d460b561-110c-7eb6-5d69-788abcca391a"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="d460b561-110c-7eb6-5d69-788abcca391a"> </a><a name="hcd460b561-110c-7eb6-5d69-788abcca391a"> </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 ObservationDefinition "d460b561-110c-7eb6-5d69-788abcca391a" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <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>#ASSAY)</span></p><p><b>method</b>: Assay by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>98-102 % w/w</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a -->
<url
value="http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"/>
<title value="Assay"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="ASSAY"/>
<display value="Assay"/>
</coding>
<text value="Assay"/>
</code>
<method>
<text value="Assay by LC"/>
</method>
<qualifiedValue>
<range>
<low>
<value value="98"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
<high>
<value value="102"/>
<unit value="% w/w"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
<resource>
<ObservationDefinition>
<!-- Impurities -->
<id value="006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </a><a name="hc006a9f7b-91ca-5601-38ef-a3dd26ad7121"> </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 ObservationDefinition "006a9f7b-91ca-5601-38ef-a3dd26ad7121" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</code></p><p><b>title</b>: Drug Substance Related Organic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Drug Substance Related Organic impurities <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>#DGP-s)</span></p><p><b>method</b>: Organic impurities by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any individual unspecified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total impurities <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <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>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"/>
<title value="Drug Substance Related Organic impurities"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="DGP-s"/>
<display value="Drug Substance Related Organic impurities"/>
</coding>
</code>
<method>
<text value="Organic impurities by LC"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity 1"/>
</appliesTo>
<range>
<high>
<value value="0.5"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Impurity 2"/>
</appliesTo>
<range>
<high>
<value value="0.5"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Any individual unspecified impurity"/>
</appliesTo>
<range>
<high>
<value value="0.10"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Total impurities"/>
</appliesTo>
<range>
<high>
<value value="2.0"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
<resource>
<ObservationDefinition>
<!-- Mutagenic -->
<id value="c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_c59deb1b-835c-1be5-4e08-95dea3ae1a17"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="c59deb1b-835c-1be5-4e08-95dea3ae1a17"> </a><a name="hcc59deb1b-835c-1be5-4e08-95dea3ae1a17"> </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 ObservationDefinition "c59deb1b-835c-1be5-4e08-95dea3ae1a17" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</code></p><p><b>title</b>: Mutagenic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Mutagenic impurities <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>#MUT)</span></p><p><b>method</b>: Impurity 5 content by LC-MS <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>AppliesTo</b></td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>Impurity - Mutagenic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>?-50</td></tr></table><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <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>#IMP)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17 -->
<url
value="http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"/>
<title value="Mutagenic impurities"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="MUT"/>
<display value="Mutagenic impurities"/>
</coding>
</code>
<method>
<text value="Impurity 5 content by LC-MS"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Impurity - Mutagenic"/>
</appliesTo>
<range>
<high>
<value value="50"/>
<unit value="ppm"/>
<system value="http://unitsofmeasure.org"/>
<code value="[ppm]"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what impurity this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="IMP"/>
<display value="Impurity"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d"/>
<resource>
<ObservationDefinition>
<!-- Enantiomeric -->
<id value="18e20bae-1a24-202d-11d7-5f354c785e4d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_18e20bae-1a24-202d-11d7-5f354c785e4d"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="18e20bae-1a24-202d-11d7-5f354c785e4d"> </a><a name="hc18e20bae-1a24-202d-11d7-5f354c785e4d"> </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 ObservationDefinition "18e20bae-1a24-202d-11d7-5f354c785e4d" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</code></p><p><b>title</b>: Enantiomeric purity</p><p><b>status</b>: active</p><p><b>code</b>: Enantiomeric purity <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>#enantiomeric-purity)</span></p><p><b>method</b>: Enantiomeric purity by LC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>99.6-? %</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d -->
<url
value="http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"/>
<title value="Enantiomeric purity"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="enantiomeric-purity"/>
<display value="Enantiomeric purity"/>
</coding>
<text value="Enantiomeric purity"/>
</code>
<method>
<text value="Enantiomeric purity by LC"/>
</method>
<qualifiedValue>
<range>
<low>
<value value="99.6"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</low>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
<resource>
<ObservationDefinition>
<!-- Solvents -->
<id value="22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </a><a name="hc22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"> </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 ObservationDefinition "22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</code></p><p><b>title</b>: Residual solvents</p><p><b>status</b>: active</p><p><b>code</b>: Residual solvents <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>#SOL)</span></p><p><b>method</b>: Residual solvents by headspace GC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.1</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Solvent <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>#SOLV)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce -->
<url
value="http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"/>
<title value="Residual solvents"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="SOL"/>
<display value="Residual solvents"/>
</coding>
</code>
<method>
<text value="Residual solvents by headspace GC"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="Solvent 1"/>
</appliesTo>
<range>
<high>
<value value="0.1"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<text value="Solvent 2"/>
</appliesTo>
<range>
<high>
<value value="2.0"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what solvent this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="SOLV"/>
<display value="Solvent"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
<resource>
<ObservationDefinition>
<!-- Water -->
<id value="b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_b4f736ff-1bbf-6923-4d5c-85d262285d7d"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="b4f736ff-1bbf-6923-4d5c-85d262285d7d"> </a><a name="hcb4f736ff-1bbf-6923-4d5c-85d262285d7d"> </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 ObservationDefinition "b4f736ff-1bbf-6923-4d5c-85d262285d7d" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <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>#WaterContent)</span></p><p><b>method</b>: USP Karl Fischer titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-1.0</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d -->
<url
value="http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"/>
<title value="Water Content"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="WaterContent"/>
<display value="Water Content"/>
</coding>
<text value="Water Content"/>
</code>
<method>
<text value="USP Karl Fischer titration"/>
</method>
<qualifiedValue>
<range>
<high>
<value value="1.0"/>
<unit value="% w/w"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:233865df-2a71-528d-756c-85f36bd6685f"/>
<resource>
<ObservationDefinition>
<!-- Particles -->
<id value="233865df-2a71-528d-756c-85f36bd6685f"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_233865df-2a71-528d-756c-85f36bd6685f"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="233865df-2a71-528d-756c-85f36bd6685f"> </a><a name="hc233865df-2a71-528d-756c-85f36bd6685f"> </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 ObservationDefinition "233865df-2a71-528d-756c-85f36bd6685f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</code></p><p><b>title</b>: Particle size distribution</p><p><b>status</b>: active</p><p><b>code</b>: Particle size distribution <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>#particle-size-distribution)</span></p><p><b>method</b>: Laser diffraction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.9) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-319</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.5) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-145</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.1) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-20</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Particle size <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>#particle-size)</span></td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f -->
<url
value="http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"/>
<title value="Particle size distribution"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="particle-size-distribution"/>
<display value="Particle size distribution"/>
</coding>
</code>
<method>
<text value="Laser diffraction"/>
</method>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="D(v,0.9)"/>
</appliesTo>
<range>
<high>
<value value="319"/>
<unit value="µm"/>
<system value="http://unitsofmeasure.org"/>
<code value="um"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="D(v,0.5)"/>
</appliesTo>
<range>
<high>
<value value="145"/>
<unit value="µm"/>
<system value="http://unitsofmeasure.org"/>
<code value="um"/>
</high>
</range>
</qualifiedValue>
<qualifiedValue>
<appliesTo>
<!-- could be a code -->
<text value="D(v,0.1)"/>
</appliesTo>
<range>
<high>
<value value="20"/>
<unit value="µm"/>
<system value="http://unitsofmeasure.org"/>
<code value="um"/>
</high>
</range>
</qualifiedValue>
<component>
<!-- are expected to have a component that says what solvent this one is -->
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
<code value="particle-size"/>
<display value="Particle size"/>
</coding>
</code>
</component>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
<resource>
<SubstanceDefinition>
<!-- substance1 -->
<id value="03d68d1c-162c-8b6e-70f9-647b0ea97adb"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </a><a name="hc03d68d1c-162c-8b6e-70f9-647b0ea97adb"> </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 SubstanceDefinition "03d68d1c-162c-8b6e-70f9-647b0ea97adb" </p></div><p><b>manufacturer</b>: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620</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</td></tr></table></div>
</text>
<manufacturer>
<!-- Organization/substance-manufacturer -->
<reference
value="Organization/062bf235-44e2-55c4-9213-bbe5e12d5620"/>
</manufacturer>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620"/>
<resource>
<Organization>
<!-- substance-manufacturer -->
<id value="062bf235-44e2-55c4-9213-bbe5e12d5620"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_062bf235-44e2-55c4-9213-bbe5e12d5620"> </a><p><b>Generated Narrative: Organization</b><a name="062bf235-44e2-55c4-9213-bbe5e12d5620"> </a><a name="hc062bf235-44e2-55c4-9213-bbe5e12d5620"> </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 "062bf235-44e2-55c4-9213-bbe5e12d5620" </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><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>
<!-- 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."/>
<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 © 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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