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
Bundle bundle-container-closure-system-pq-ex1-prod of type collection
Entry 1 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Textual description of the product
combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)
route: Oral use (standardterms.edqm.eu#20053000)
name
productName: Stelbat Tablets, 20mg
type: Proprietary (Product Name Type - example#Proprietary)
Parts
Part Type 20mg Strength part (Product Name Part Type#StrengthPart)
Entry 2 - fullUrl = urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f14bc3923"
Profile: PackagedProductDefinition - Drug PQ
packageFor: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
containedItemQuantity: 28 tablets
description: 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.
packaging
type: Bottle (Packaging Type#100000073497)
material: High Density PolyEthylene (Package Material#200000003215)
manufacturer: : Container Co. of America
property
type: Color (Package Property Codes#Color)
value: White (Drug Substance or Product Color Codes#white)
property
type: Quality Standard (Package Property Codes#Quality Standard)
value: USP <661> Plastic Packaging Systems and Their Materials of Construction (Package Grade Codes#USP)
property
type: Quality Standard (Package Property Codes#Quality Standard)
value: PhEur 3.1.3 Polyolefins (Package Grade Codes#PhEur)
packaging
Entry 3 - fullUrl = urn:uuid:88a068e2-1d97-337b-3b9c-4b3f24bc3923
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f24bc3923"
Profile: PackagedProductDefinition - Drug PQ
packageFor: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
containedItemQuantity: 28 tablets
description: 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.
packaging
property
type: Quality Standard (Package Property Codes#Quality Standard)
value: European Commission Regulation 1935/2004 (Package Grade Codes#EU1935-2004)
property
type: Quality Standard (Package Property Codes#Quality Standard)
value: European Union Council Directive 78/142/EEC (Package Grade Codes#EU78-142)
packaging