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 (CodeSystem - Product Name Type#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 above (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 (CodeSystem - Package Property#Color)

value: White (CodeSystem - Color#white)

property

type: Quality Standard (CodeSystem - Package Property#Quality Standard)

value: USP <661> Plastic Packaging Systems and Their Materials of Construction (CodeSystem - Grade#USP)

property

type: Quality Standard (CodeSystem - Package Property#Quality Standard)

value: PhEur 3.1.3 Polyolefins (CodeSystem - Grade#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 above (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 (CodeSystem - Package Property#Quality Standard)

value: European Commission Regulation 1935/2004 (CodeSystem - Grade#EU1935-2004)

property

type: Quality Standard (CodeSystem - Package Property#Quality Standard)

value: European Union Council Directive 78/142/EEC (CodeSystem - Grade#EU78-142)

packaging