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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundle-container-closure-system-pq-ex1-prod"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq> ] ) ] ; # fhir:type [ fhir:v "collection"] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> ) # Section 1.1 - DP Identification ] [ fhir:fullUrl [ fhir:v "urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:88a068e2-1d97-337b-3b9c-4b3f24bc3923"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:88a068e2-1d97-337b-3b9c-4b3f24bc3923> ) ] ) . # MedicinalProductDefinition - the main resource in any product scenario <urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"] ; # medicinalproductdefinition-drug-product-dxpq-ex1 fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>" ] ; # fhir:description [ fhir:v "Textual description of the product"] ; # fhir:combinedPharmaceuticalDoseForm [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "10225000" ] ; fhir:display [ fhir:v "Gastro-resistant tablet" ] ] ) ] ; # fhir:route ( [ ( fhir:coding [ fhir:system [ fhir:v "http://standardterms.edqm.eu"^^xsd:anyURI ] ; fhir:code [ fhir:v "20053000" ] ; fhir:display [ fhir:v "Oral use" ] ] ) ] ) ; # fhir:name ( [ fhir:productName [ fhir:v "Stelbat Tablets, 20mg" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"^^xsd:anyURI ] ; fhir:code [ fhir:v "Proprietary" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "20mg" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-name-part-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "StrengthPart" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] ) ] ) . # <urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "88a068e2-1d97-337b-3b9c-4b3f14bc3923"] ; # packagedproductdefinition-dxpq-ex1 fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_88a068e2-1d97-337b-3b9c-4b3f14bc3923\"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"88a068e2-1d97-337b-3b9c-4b3f14bc3923\"> </a><a name=\"hc88a068e2-1d97-337b-3b9c-4b3f14bc3923\"> </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 PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f14bc3923" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PackagedProductDefinition-drug-pq.html\">PackagedProductDefinition - Drug PQ</a></p></div><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>containedItemQuantity</b>: 28 tablets</p><p><b>description</b>: The container closure system consists of a bottle and closure. The bottle is manufactured from white high-density polyethylene (HDPE). The 2-piece child-resistant closure is manufactured from polypropylene (PP) and contains a multi-layer aluminum foil seal liner for tamper evidence. The bottle and closure provide an adequate barrier to moisture and light, which protect the drug product. The container closure system has demonstrated suitability for storage of the drug product based on stability studies shown in 3.2.P.8.3. The HDPE bottle has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction and PhEur 3.1.3 Polyolefins. The product contacting aluminum foil seal liner has demonstrated compliance with USP <661>. The vendor has confirmed compliance with 21 CFR 175.300, in addition to compliance with limitation of heavy metals per EU 94/62/EC, Article 11. The container closure system has demonstrated child resistance in compliance with 16 CFR 1700. Detailed information pertaining to the bottle and closure is described in 3.2.P.7.</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Bottle <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-packaging-type.html\">Packaging Type</a>#100000073497)</span></p><p><b>material</b>: High Density PolyEthylene <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003215)</span></p><p><b>manufacturer</b>: <span>: Container Co. of America</span></p><blockquote><p><b>property</b></p><p><b>type</b>: Color <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-property.html\">Package Property Codes</a>#Color)</span></p><p><b>value</b>: White <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-drug-substance-or-product-color.html\">Drug Substance or Product Color Codes</a>#white)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-property.html\">Package Property Codes</a>#Quality Standard)</span></p><p><b>value</b>: USP <661> Plastic Packaging Systems and Their Materials of Construction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-grade.html\">Package Grade Codes</a>#USP)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-property.html\">Package Property Codes</a>#Quality Standard)</span></p><p><b>value</b>: PhEur 3.1.3 Polyolefins <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-grade.html\">Package Grade Codes</a>#PhEur)</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Child Proof Cap <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-container-closure-type.html\">Closure Type Codes</a>#Child Proof Cap)</span></p><p><b>componentPart</b>: true</p><p><b>material</b>: PolyPropylene <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003219)</span></p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>packaging</b></p></blockquote></blockquote></blockquote></div>" ] ; # fhir:packageFor ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ) ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "28"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablets" ] ] ) ; # fhir:description [ fhir:v "The container closure system consists of a bottle and closure. The bottle is manufactured from white high-density polyethylene (HDPE). The 2-piece child-resistant closure is manufactured from polypropylene (PP) and contains a multi-layer aluminum foil seal liner for tamper evidence. The bottle and closure provide an adequate barrier to moisture and light, which protect the drug product. The container closure system has demonstrated suitability for storage of the drug product based on stability studies shown in 3.2.P.8.3. The HDPE bottle has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction and PhEur 3.1.3 Polyolefins. The product contacting aluminum foil seal liner has demonstrated compliance with USP <661>. The vendor has confirmed compliance with 21 CFR 175.300, in addition to compliance with limitation of heavy metals per EU 94/62/EC, Article 11. The container closure system has demonstrated child resistance in compliance with 16 CFR 1700. Detailed information pertaining to the bottle and closure is described in 3.2.P.7."] ; # fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/packaging-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000073497" ] ; fhir:display [ fhir:v "Bottle" ] ] ) ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003215" ] ; fhir:display [ fhir:v "High Density PolyEthylene" ] ] ) ] ) ; ( fhir:manufacturer [ fhir:display [ fhir:v "Container Co. of America" ] ] ) ; ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Color" ] ; fhir:display [ fhir:v "Color" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/drug-substance-or-product-color"^^xsd:anyURI ] ; fhir:code [ fhir:v "white" ] ; fhir:display [ fhir:v "White" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "USP" ] ; fhir:display [ fhir:v "USP <661> Plastic Packaging Systems and Their Materials of Construction" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "PhEur" ] ; fhir:display [ fhir:v "PhEur 3.1.3 Polyolefins" ] ] ) ] ] ) ; ( fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-closure-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Child Proof Cap" ] ; fhir:display [ fhir:v "Child Proof Cap" ] ] ) ] ; fhir:componentPart [ fhir:v "true"^^xsd:boolean ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003219" ] ; # TODO use EMA ones fhir:display [ fhir:v "PolyPropylene" ] ] ) ] ) ; ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "16CFR1700" ] ; fhir:display [ fhir:v "16 CFR 1700" ] ] ) ] ] ) ; ( fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-closure-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Multi-layer Foil Seal Liner" ] ; fhir:display [ fhir:v "Multi-layer Foil Seal Liner" ] ] ) ] ; fhir:componentPart [ fhir:v "true"^^xsd:boolean ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003200" ] ; fhir:display [ fhir:v "Aluminium" ] ] ) ] ) ; ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "21CFR175.300" ] ; fhir:display [ fhir:v "21 CFR 175.300" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU-94-62-EC" ] ; fhir:display [ fhir:v "EU 94/62/EC" ] ] ) ] ] ) ] ) ] ) ] . # <urn:uuid:88a068e2-1d97-337b-3b9c-4b3f24bc3923> a fhir:PackagedProductDefinition ; fhir:id [ fhir:v "88a068e2-1d97-337b-3b9c-4b3f24bc3923"] ; # packagedproductdefinition-dxpq-ex2 fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_88a068e2-1d97-337b-3b9c-4b3f24bc3923\"> </a><p><b>Generated Narrative: PackagedProductDefinition</b><a name=\"88a068e2-1d97-337b-3b9c-4b3f24bc3923\"> </a><a name=\"hc88a068e2-1d97-337b-3b9c-4b3f24bc3923\"> </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 PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f24bc3923" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PackagedProductDefinition-drug-pq.html\">PackagedProductDefinition - Drug PQ</a></p></div><p><b>packageFor</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>containedItemQuantity</b>: 28 tablets</p><p><b>description</b>: The container closure system consists of a blister film of 150 µm thick polyvinyl chloride (PVC) and a blister lidding of 10 µm hard temper push-through aluminum foil with a product contact heat seal layer of polyvinyl chloride (PVC) laminated in Aclar. The PVC blister film effectively seals with the aluminum foil heat seal layer during final packaging. The blister film and foil materials have demonstrated suitability for product storage based on stability studies shown in 3.2.P.8.3 and additional testing. The film has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction, PhEur 3.1.11 Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration, and PhEur 3.2.2 Plastic Containers and Closures for Pharmaceutical Use. Additionally, the film conforms to European Union Regulation 10/2011. The lidding foil has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction. The foil complex is stated to conform to European Commission Regulation 1935/2004 and the heat seal layer conforms to European Union Council Directive 78/142/EEC. Additionally, an infrared reflectance spectrum was obtained to confirm the identity of the material. Detailed information pertaining to the blisters is described in 3.2.P.7.</p><blockquote><p><b>packaging</b></p><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-property.html\">Package Property Codes</a>#Quality Standard)</span></p><p><b>value</b>: European Commission Regulation 1935/2004 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-grade.html\">Package Grade Codes</a>#EU1935-2004)</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Quality Standard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-property.html\">Package Property Codes</a>#Quality Standard)</span></p><p><b>value</b>: European Union Council Directive 78/142/EEC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-package-grade.html\">Package Grade Codes</a>#EU78-142)</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: Blister <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-container-closure-type.html\">Closure Type Codes</a>#Blister)</span></p><p><b>quantity</b>: 2</p><p><b>material</b>: PolyVinyl Chloride <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-package-material.html\">Package Material</a>#200000003222)</span></p><p><b>manufacturer</b>: <span>: Plastics of America</span></p><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>property</b></p></blockquote><blockquote><p><b>containedItem</b></p></blockquote><blockquote><p><b>packaging</b></p></blockquote></blockquote></blockquote></div>" ] ; # fhir:packageFor ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" ] # MedicinalProductDefinition\/medicinalproductdefinition-drug-product-dxpq-ex1 ] ) ; # fhir:containedItemQuantity ( [ fhir:value [ fhir:v "28"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablets" ] ] ) ; # fhir:description [ fhir:v "The container closure system consists of a blister film of 150 µm thick polyvinyl chloride (PVC) and a blister lidding of 10 µm hard temper push-through aluminum foil with a product contact heat seal layer of polyvinyl chloride (PVC) laminated in Aclar. The PVC blister film effectively seals with the aluminum foil heat seal layer during final packaging. The blister film and foil materials have demonstrated suitability for product storage based on stability studies shown in 3.2.P.8.3 and additional testing. The film has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction, PhEur 3.1.11 Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration, and PhEur 3.2.2 Plastic Containers and Closures for Pharmaceutical Use. Additionally, the film conforms to European Union Regulation 10/2011. The lidding foil has demonstrated compliance with USP <661> Plastic Packaging Systems and Their Materials of Construction. The foil complex is stated to conform to European Commission Regulation 1935/2004 and the heat seal layer conforms to European Union Council Directive 78/142/EEC. Additionally, an infrared reflectance spectrum was obtained to confirm the identity of the material. Detailed information pertaining to the blisters is described in 3.2.P.7."] ; # fhir:packaging [ ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU1935-2004" ] ; fhir:display [ fhir:v "European Commission Regulation 1935/2004" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU78-142" ] ; fhir:display [ fhir:v "European Union Council Directive 78/142/EEC" ] ] ) ] ] ) ; # type>\n \n <\/type, technically this is a property of the \"foil complex\" ( fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-closure-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Blister" ] ; fhir:display [ fhir:v "Blister" ] ] ) # the actual blister ] ; fhir:quantity [ fhir:v "2"^^xsd:integer ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003222" ] ; fhir:display [ fhir:v "PolyVinyl Chloride" ] ] ) ] ) ; ( fhir:manufacturer [ fhir:display [ fhir:v "Plastics of America" ] ] ) ; ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Thickness" ] ; fhir:display [ fhir:v "Thickness" ] ] ) ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "150"^^xsd:decimal ] ; fhir:unit [ fhir:v "µm" ] ] # todo ucum ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "USP" ] ; fhir:display [ fhir:v "USP <661> Plastic Packaging Systems and Their Materials of Construction" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "PhEur3111" ] ; fhir:display [ fhir:v "Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "PhEur322" ] ; fhir:display [ fhir:v "Plastic Containers and Closures for Pharmaceutical Use" ] ] ) ] ] ) ; ( fhir:containedItem [ fhir:item [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/data-absent-reason"^^xsd:anyURI ] ; fhir:value [ fhir:v "unsupported" ] ] ) ] ; fhir:amount [ fhir:value [ fhir:v "14"^^xsd:decimal ] ; fhir:unit [ fhir:v "tablets" ] ] ] ) ; ( fhir:packaging [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/container-closure-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "Blister Foil Lidding" ] ; fhir:display [ fhir:v "Blister Foil Lidding" ] ] ) ] ; fhir:componentPart [ fhir:v "true"^^xsd:boolean ] ; ( fhir:material [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/package-material"^^xsd:anyURI ] ; fhir:code [ fhir:v "200000003200" ] ; # TODO use EMA ones fhir:display [ fhir:v "Aluminium" ] ] ) ] ) ; ( fhir:manufacturer [ fhir:display [ fhir:v "Reynolds Wrap USA" ] ] ) ; ( fhir:property [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "USP" ] ; fhir:display [ fhir:v "USP <661> Plastic Packaging Systems and Their Materials of Construction" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Quality Standard" ] ; fhir:display [ fhir:v "Quality Standard" ] ] ) ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-grade"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU10-2011" ] ; fhir:display [ fhir:v "European Union Regulation 10/2011" ] ] ) ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/package-property"^^xsd:anyURI ] ; fhir:code [ fhir:v "Thickness" ] ; fhir:display [ fhir:v "Thickness" ] ] ) ] ; fhir:value [ a fhir:Quantity ; fhir:value [ fhir:v "10"^^xsd:decimal ] ; fhir:unit [ fhir:v "µm" ] ] # todo ucum ] ) ] ) ] ) ] . #
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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