Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-drug-product-microbiological-attributes-pq-ex1",
"meta" : // Product Microbiological Attributes
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-microbiological-attributes-pq"
]
},
"type" : "collection",
"entry" : [
// Diagnostic report doesn't carry much extra value but does collect all the observations
{
"fullUrl" : "urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd",
"resource" : {
"resourceType" : "DiagnosticReport",
"id" : "microbiologicalReport",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"DiagnosticReport_microbiologicalReport\"> </a><p><b>Generated Narrative: DiagnosticReport</b><a name=\"microbiologicalReport\"> </a><a name=\"hcmicrobiologicalReport\"> </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 DiagnosticReport "microbiologicalReport" </p></div><p><b>status</b>: final</p><p><b>code</b>: Microbiological Attributes Report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-report-type.html\">Pharmaceutical Report Type Codes</a>#Microbiological Attributes Report)</span></p><p><b>subject</b>: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51</p><p><b>effective</b>: 2020-12</p><p><b>result</b>: See on this page: Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d</p></div>"
},
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type",
"code" : "Microbiological Attributes Report",
"display" : "Microbiological Attributes Report"
}
]
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2020-12",
"result" : [
// Medication/medication-actual-batch
// start of stability test
{
"reference" : "Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d"
}
]
}
},
// Observation/observationDescription
{
"fullUrl" : "urn:uuid:18c2d9e0-08c7-84e2-5e59-8f56321f895d",
"resource" : {
"resourceType" : "Observation",
"id" : "18c2d9e0-08c7-84e2-5e59-8f56321f895d",
"text" : // observationDescription
{
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <div style=\"font-family: 'Times New Roman', Times, serif;\">\n <p>\n <span>The microbiological attributes of the excipients were\n characterized during the development program. All excipients\n meet USP <1111> </span>\n <i>\n <span>Microbial Examination of\n Nonsterile Products:</span>\n </i>\n <span> </span>\n <i>\n <span>Acceptance Criteria for Pharmaceutical\n Preparations and Substances for Pharmaceutical\n Use</span>\n </i>\n <span> </span>\n <span>and Ph. Eur. 5.1.4\n </span>\n <i>\n <span>Microbiological quality of non-sterile\n pharmaceutical preparations and substances for\n pharmaceutical use</span>\n </i>\n <i>\n <span>,</span>\n </i>\n <span>\n when tested in accordance with USP <61> and\n <62>,</span>\n <span> </span>\n <span>and Ph. Eur. 2.6.12 and\n 2.6.13, where applicable.</span>\n </p>\n <p>\n <span>Current Good Manufacturing Practices are used which minimize\n the possibility for microbial contamination for the finished\n product. This was confirmed via testing of three lots\n manufactured at the commercial scale for the purpose of PPQ and\n stability studies according to USP <61> and <62>.\n All lots met the USP <1111> criteria for nonaqueous\n preparations for oral use (Total Aerobic Microbial Count NMT\n 10<sup>3</sup> CFU/gram, Total Combined Yeast and Mold Count\n NMT 10<sup>2</sup> CFU/gram and absence of\n </span>\n <i>\n <span>Escherichia coli </span>\n </i>\n <span>in 1\n gram), as stated in Sections 3.2.P.5.4 and 3.2.P.8.3.</span>\n </p>\n <p>\n <span>Per USP <921> </span>\n <i>\n <span>Water\n Determination</span>\n </i>\n <span>, the drug product specification\n is set to NMT 1.0% at release and NMT 2.0% for shelf life as\n described in Section 3.2.P.5.1. The water activity for the drug\n product was confirmed to comply with the specifications as\n stated in Sections 3.2.P.5.4 and 3.2.P.8.3. </span>\n </p>\n <p>\n <span>A product microbial risk evaluation conducted for the drug\n product manufacturing site supports annual microbiological\n quality testing at release and on stability following the\n specification listed in Section 3.2.P.5.1. Input material,\n manufacturing, process controls as well as environmental\n controls are all in place to ensure consistent microbiological\n quality. The excipients used in the manufacture of the product\n are tested for microbiological quality as required by their\n respective compendial requirements. This product demonstrates\n satisfactory microbiological quality based on the results of all\n batches evaluated. Microbiological quality testing will continue\n to be monitored annually on the drug product for release and\n throughout the stability study.</span>\n </p>\n </div>\n </div>"
},
"status" : "final",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Medication/medication-actual-batch
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Complies"
}
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"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\"><a name=\"MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><a name=\"hca0694a7a-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>description</b>: Textual description of the product</p><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-pq-example.html\">Product Name Type - example</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>"
},
"description" : "Textual description of the product",
"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-pq-example",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"resource" : {
"resourceType" : "Medication",
"id" : "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"text" : // medication-actual-batch
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><p><b>Generated Narrative: Medication</b><a name=\"339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><a name=\"hc339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </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 Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
}
}
},
// todo consider change this be the MID?
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b08",
"text" : // testing lab
// 378fbe5f-5926-3a5c-4c64-5428df877b08
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\"> </a><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b08\"> </a><a name=\"hc378fbe5f-5926-3a5c-4c64-5428df877b08\"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3007270600</p><p><b>active</b>: true</p><p><b>type</b>: Analytical Testing - Release <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#analytical-testing-release)</span></p><p><b>name</b>: Testing Lab</p></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3007270600"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
"code" : "analytical-testing-release",
"display" : "Analytical Testing - Release"
}
]
}
],
"name" : "Testing Lab"
}
}
]
}
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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