Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

## Container Closure System: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.7 Container Closure System.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-container-closure-system-pq-ex1-prod
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq
Type: collection
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stelbat Tablets, 20mg
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)
Strength name part: 20mg
Description: Textual description of the product
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Package (1 of 2) [documentation R4 R5 R6]
id: packagedproductdefinition-dxpq-ex1
fullUrl: urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq
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.
Contained Items: 28 tablets
Packaging - Bottle [100000073497] (http://hl7.org/fhir/packaging-type)
Type: Bottle [100000073497] (http://hl7.org/fhir/packaging-type)
Material: High Density PolyEthylene [200000003215] (http://hl7.org/fhir/package-material)
Manufacturer
Display: Container Co. of America
Property
Type: Color [Color] (http://terminology.hl7.org/CodeSystem/package-property)
Value: White [white] (http://terminology.hl7.org/CodeSystem/drug-substance-or-product-color)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: USP <661> Plastic Packaging Systems and Their Materials of Construction [USP] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: PhEur 3.1.3 Polyolefins [PhEur] (http://terminology.hl7.org/CodeSystem/package-grade)
Packaging (part) - Child Proof Cap [Child Proof Cap] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Type: Child Proof Cap [Child Proof Cap] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Component Part: true
Material: PolyPropylene [200000003219] (http://hl7.org/fhir/package-material)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: 16 CFR 1700 [16CFR1700] (http://terminology.hl7.org/CodeSystem/package-grade)
Packaging (part) - Multi-layer Foil Seal Liner [Multi-layer Foil Seal Liner] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Type: Multi-layer Foil Seal Liner [Multi-layer Foil Seal Liner] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Component Part: true
Material: Aluminium [200000003200] (http://hl7.org/fhir/package-material)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: 21 CFR 175.300 [21CFR175.300] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: EU 94/62/EC [EU-94-62-EC] (http://terminology.hl7.org/CodeSystem/package-grade)
↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Package (2 of 2) [documentation R4 R5 R6]
id: packagedproductdefinition-dxpq-ex2
fullUrl: urn:uuid:88a068e2-1d97-337b-3b9c-4b3f24bc3923
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq
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.
Contained Items: 28 tablets
Packaging
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: European Commission Regulation 1935/2004 [EU1935-2004] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: European Union Council Directive 78/142/EEC [EU78-142] (http://terminology.hl7.org/CodeSystem/package-grade)
Packaging - Blister [Blister] (http://terminology.hl7.org/CodeSystem/container-closure-type), 2
Type: Blister [Blister] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Quantity: 2
Material: PolyVinyl Chloride [200000003222] (http://hl7.org/fhir/package-material)
Manufacturer
Display: Plastics of America
Property
Type: Thickness [Thickness] (http://terminology.hl7.org/CodeSystem/package-property)
Value: 150 µm
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: USP <661> Plastic Packaging Systems and Their Materials of Construction [USP] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: Materials Based on Non-Plasticised Poly Vinyl Chloride for Containers for Solid Dosage Forms and Oral Administration [PhEur3111] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: Plastic Containers and Closures for Pharmaceutical Use [PhEur322] (http://terminology.hl7.org/CodeSystem/package-grade)
Packaging (part) - Blister Foil Lidding [Blister Foil Lidding] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Type: Blister Foil Lidding [Blister Foil Lidding] (http://terminology.hl7.org/CodeSystem/container-closure-type)
Component Part: true
Material: Aluminium [200000003200] (http://hl7.org/fhir/package-material)
Manufacturer
Display: Reynolds Wrap USA
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: USP <661> Plastic Packaging Systems and Their Materials of Construction [USP] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Quality Standard [Quality Standard] (http://terminology.hl7.org/CodeSystem/package-property)
Value: European Union Regulation 10/2011 [EU10-2011] (http://terminology.hl7.org/CodeSystem/package-grade)
Property
Type: Thickness [Thickness] (http://terminology.hl7.org/CodeSystem/package-property)
Value: 10 µm
Amount: 14 tablets