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
// Product Analytical Procedure
{
"resourceType" : "Bundle",
"id" : "bundle-analytical-procedure-pq-ex1-prod",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "analyticalProcedure",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"analyticalProcedure\"> </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 "analyticalProcedure" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html\">PlanDefinitionType</a>#workflow-definition; <a href=\"CodeSystem-cs-planType-local-pq.html\">CodeSystem - Plan Type</a>#analytical-procedure "Analytical Procedure")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></p><blockquote><p><b>action</b></p><p><b>title</b>: Preparation and Analysis of Drug Product Samples</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Diluent</span></p><p><b>role</b>: Diluent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#diluent)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-manufacturingParticipantRole-local-pq.html\">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f",
"title" : "Analytical Procedure",
"type" : // http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq",
"code" : "analytical-procedure",
"display" : "Analytical Procedure"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
},
"action" : [
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"title" : "Preparation and Analysis of Drug Product Samples",
"participant" : [
{
"typeReference" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f81"
}
}
],
"display" : "Diluent"
},
"role" : // SubstanceDefinition/diluent
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "diluent",
"display" : "Diluent"
}
]
}
},
{
"typeReference" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq",
"valueReference" : {
"reference" : "SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"
}
}
],
"display" : "Resulting material"
},
"role" : // SubstanceDefinition/resultingMaterial
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq",
"code" : "ResultingMaterial",
"display" : "Resulting Material"
}
]
}
}
],
"action" : [
{
"title" : "Sample Preparation",
"action" : [
{
"title" : "Instructions",
"description" : "Transfer 5 tablets into a volumetric flask. Add a portion of the diluent and shake on mechanical shaker until tablets are completely disintegrated. Dilute to volume with diluent. Do not exceed 2 mg/mL in the initial dilution. Filter or centrifuge."
}
]
},
{
"title" : "Sample Analysis",
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"
}
]
}
]
}
]
}
},
// ObservationDefinition/SampleAnalysis
{
"fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f81",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "9f69ec9c-5fd1-30d2-0790-9e8035565f81",
"text" : // diluent
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f81\"> </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 "9f69ec9c-5fd1-30d2-0790-9e8035565f81" </p></div><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>0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)</td></tr></table></div>"
},
"name" : [
{
"name" : "0.05 % trifluoroacetic acid (TFA) in 50:50 acetonitrile: water (v/v)"
}
]
}
},
{
"fullUrl" : "urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "9f69ec9c-5fd1-30d2-0790-9e8035565f82",
"text" : // resultingMaterial
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"9f69ec9c-5fd1-30d2-0790-9e8035565f82\"> </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 "9f69ec9c-5fd1-30d2-0790-9e8035565f82" </p></div><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>Stelbat in Diluent (approximately 0.36 mg/mL)</td></tr></table></div>"
},
"name" : [
{
"name" : "Stelbat in Diluent (approximately 0.36 mg/mL)"
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"text" : // SampleAnalysis
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4136-3c1f-b8ba6a7d046e\"> </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 "12e7e672-40a6-4136-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Sample Analysis</p><p><b>status</b>: active</p><p><b>description</b>: Number of Injections: 1 of each preparation</p><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>specimen</b>: <a href=\"#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>hasMember</b>: </p><ul><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href=\"#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e\">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e)</a></li></ul></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e",
"title" : "Sample Analysis",
"status" : "active",
"description" : "Number of Injections: 1 of each preparation",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/data-absent-reason",
"valueCode" : "unsupported"
}
]
},
"specimen" : [
{
"reference" : "SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"
}
],
"hasMember" : [
// SpecimenDefinition/specimendefinition
{
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"
},
// ObservationDefinition/Assay
{
"reference" : "ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"
}
]
}
},
// ObservationDefinition/Identity
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"text" : // Assay
{
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <div style=\"font-family: 'Times New Roman', Times, serif;\">\n <p>Determine the amount of Stelbat in each sample replicate as follows:</p>\n <p>\n \n <!-- <img alt=\"formula\" width=\"203\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource\"/> -->\n </p>\n <p>\n <span>Where:</span>\n </p>\n <p>\n <span>A\n <sub>SPL</sub>\u00a0\u00a0\u00a0\u00a0\u00a0 =\u00a0 Area of Stelbat in the sample \n </span>\n </p>\n <p>\n <span>ANSR\u00a0\u00a0 =\u00a0 Average normalized standard response factor of standard injections</span>\n </p>\n <p>\n <span>DF\u00a0\u00a0\u00a0\u00a0\u00a0=\u00a0 Overall sample dilution factor</span>\n </p>\n <p>\n <span>N\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0= Number of tablets in sample preparation</span>\n </p>\n <p>\n <span>Determine the % label claim of the sample as follows:</span>\n </p>\n <p>\n \n <!-- <img alt=\"formula\" width=\"220\" height=\"34\" style=\"display: block; margin-left: auto; margin-right: auto;\" src=\"#imageResource2\"/> -->\n </p>\n <p>\n <span>Where:</span>\n </p>\n <p>\n <span>LC\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 = \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Label claim (mg/tablet) of tested sample</span>\n </p>\n </div>\n </div>"
},
"contained" : [
{
"resourceType" : "Binary",
"id" : "imageResource",
"contentType" : "image/png",
"data" : "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"
},
// example format
// data is base 64 encoded, actual bytes of the image png file
{
"resourceType" : "Binary",
"id" : "imageResource2",
"contentType" : "image/png",
"data" : "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"
}
],
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e",
"title" : "Assay (w/w%)",
"status" : "active",
"code" : // example format
// data is base 64 encoded, actual bytes of the image png file
// http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay (w/w%)"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "The %RSD between the two assay results must be ≤ 1.5%"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"text" : // Identity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"12e7e672-40a6-4036-3c1f-b8ba6a7d046e\"> </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 "12e7e672-40a6-4036-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Identity</p><p><b>status</b>: active</p><p><b>code</b>: Identity <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 "Identification")</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>, </td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e",
"title" : "Identity",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identity"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "1. The retention time ratio of the sample peak to standard peak is within 0.95 to 1.05."
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "2. The UV spectrum of the sample peak compares favorably to the UV spectrum of the standard peak from 210 nm to 400 nm."
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"resource" : {
"resourceType" : "SpecimenDefinition",
"id" : "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"text" : // specimendefinition
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SpecimenDefinition</b><a name=\"3a0cde98-4a73-6d67-1dfc-08e3fc9646a2\"> </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 SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 2 (only 1 is required for identity)</p><blockquote><p><b>typeTested</b></p><p><b>preference</b>: preferred</p><blockquote><p><b>handling</b></p><h3>MaxDurations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Value</b></td><td><b>Unit</b></td></tr><tr><td style=\"display: none\">*</td><td>4</td><td>days</td></tr></table><p><b>instruction</b>: at ambient or refrigerated conditions protected from light (may be extended with supporting data)</p></blockquote></blockquote></div>"
},
"url" : "http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2",
"status" : "active",
"description" : "Number of Preparations: 2 (only 1 is required for identity)",
"typeTested" : [
// http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
{
"preference" : "preferred",
"handling" : [
{
"maxDuration" : {
"value" : 4,
"unit" : "days"
},
"instruction" : "at ambient or refrigerated conditions protected from light (may be extended with supporting data)"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-dxpq-ex1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </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 MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-local-pq.html\">CodeSystem - Product Name Type</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
},
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stelbat Tablets, 20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-local-pq",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
}
]
}
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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