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
// Substance Specification
{
"resourceType" : "Bundle",
"id" : "bundle-drug-substance-specification-pq-ex1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "specificationProtocol",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"specificationProtocol\"> </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>: <a href=\"#SubstanceDefinition_03d68d1c-162c-8b6e-70f9-647b0ea97adb\">See above (SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb)</a></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><code>ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f</code></td></tr></table></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a",
"title" : "SPECIFICATION FOR DRUG SUBSTANCE",
"status" : "active",
"subjectReference" : // http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
{
"reference" : "SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb"
},
"description" : "Narrative description of specifications",
"action" : [
// SubstanceDefinition/substance1
{
"title" : "Specification for Drug Substance",
"code" : // this is then entire thing
{
"text" : "Overall set of actions"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9"
},
// ObservationDefinition/Description
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3"
},
// ObservationDefinition/Identification
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a"
},
// ObservationDefinition/Assay
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121"
},
// ObservationDefinition/Impurities
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17"
},
// ObservationDefinition/Mutagenic
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d"
},
// ObservationDefinition/Enantiomeric
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"
},
// ObservationDefinition/Solvents
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d"
},
// ObservationDefinition/Water
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f"
}
]
}
]
}
},
// ObservationDefinition/Particles
{
"fullUrl" : "urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "52176085-1f30-0c67-9ad7-523c486c82c9",
"text" : // Description
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"52176085-1f30-0c67-9ad7-523c486c82c9\"> </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.html\">CodeSystem - 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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"method" : {
"text" : "Visual inspection"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "A white to brown powder"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:b50d892c-8980-0774-39d4-d449732873a3",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "b50d892c-8980-0774-39d4-d449732873a3",
"text" : // Identification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"b50d892c-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.html\">CodeSystem - 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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"method" : {
"text" : "Identification by IR spectroscopy Identification by HPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Conforms with reference"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "d460b561-110c-7eb6-5d69-788abcca391a",
"text" : // Assay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d460b561-110c-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.html\">CodeSystem - 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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"method" : {
"text" : "Assay by LC"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 98,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 102,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "006a9f7b-91ca-5601-38ef-a3dd26ad7121",
"text" : // Impurities
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"006a9f7b-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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121",
"title" : "Drug Substance Related Organic impurities",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP-s",
"display" : "Drug Substance Related Organic impurities"
}
]
},
"method" : {
"text" : "Organic impurities by LC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Any individual unspecified impurity"
}
],
"range" : {
"high" : {
"value" : 0.10,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Total impurities"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "c59deb1b-835c-1be5-4e08-95dea3ae1a17",
"text" : // Mutagenic
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"c59deb1b-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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17",
"title" : "Mutagenic impurities",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "MUT",
"display" : "Mutagenic impurities"
}
]
},
"method" : {
"text" : "Impurity 5 content by LC-MS"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity - Mutagenic"
}
],
"range" : // could be a code
{
"high" : {
"value" : 50,
"unit" : "ppm",
"system" : "http://unitsofmeasure.org",
"code" : "[ppm]"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "18e20bae-1a24-202d-11d7-5f354c785e4d",
"text" : // Enantiomeric
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"18e20bae-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.html\">CodeSystem - 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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d",
"title" : "Enantiomeric purity",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "enantiomeric-purity",
"display" : "Enantiomeric purity"
}
],
"text" : "Enantiomeric purity"
},
"method" : {
"text" : "Enantiomeric purity by LC"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 99.6,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
"text" : // Solvents
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"22544fa4-0fa2-1d5a-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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce",
"title" : "Residual solvents",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"method" : {
"text" : "Residual solvents by headspace GC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Solvent 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.1,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Solvent 2"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what solvent this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "b4f736ff-1bbf-6923-4d5c-85d262285d7d",
"text" : // Water
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"b4f736ff-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.html\">CodeSystem - 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>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP Karl Fischer titration"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.0,
"unit" : "% w/w"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:233865df-2a71-528d-756c-85f36bd6685f",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "233865df-2a71-528d-756c-85f36bd6685f",
"text" : // Particles
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"233865df-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.html\">CodeSystem - 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.html\">CodeSystem - Example Local Codes - Drug</a>#particle-size)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f",
"title" : "Particle size distribution",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "particle-size-distribution",
"display" : "Particle size distribution"
}
]
},
"method" : {
"text" : "Laser diffraction"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "D(v,0.9)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 319,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
},
{
"appliesTo" : [
{
"text" : "D(v,0.5)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 145,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
},
{
"appliesTo" : [
{
"text" : "D(v,0.1)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 20,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what solvent this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "particle-size",
"display" : "Particle size"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "03d68d1c-162c-8b6e-70f9-647b0ea97adb",
"text" : // substance1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"03d68d1c-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>: <a href=\"#Organization_062bf235-44e2-55c4-9213-bbe5e12d5620\">See above (Organization/062bf235-44e2-55c4-9213-bbe5e12d5620)</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</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/062bf235-44e2-55c4-9213-bbe5e12d5620"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620",
"resource" : {
"resourceType" : "Organization",
"id" : "062bf235-44e2-55c4-9213-bbe5e12d5620",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"062bf235-44e2-55c4-9213-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>: id:\u00a03003040516</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>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
}
]
}
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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