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Pharmaceutical Packaging Material Requirements

Pharmaceutical Packaging Material Requirements, Total:146 items.

In the international standard classification, Pharmaceutical Packaging Material Requirements involves: Quality, Medical equipment, Pharmaceutics, Packaging materials and accessories, Packaging and distribution of goods in general, Wastes, Company organization and management, Farm buildings, structures and installations, Equipment for children, Domestic safety, Protection against dangerous goods, Food products in general, Vocabularies, Plastics, Paper products, Environmental protection, Sterilization and disinfection, Applications of information technology, Products of the chemical industry, Rubber and plastics products, Photography.


European Committee for Standardization (CEN), Pharmaceutical Packaging Material Requirements

  • EN ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008@ with reference to Good Manufacturing Practice (GMP) (Remains Current)
  • prEN 868-2-1992 Packaging materials for sterilization of wrapped goods; part 2: sterilization wrap; requirements and tests
  • prEN 868-4-1992 Packaging materials for sterilization of wrapped goods; part 4: paper bags; requirements and tests
  • EN ISO 15378:2011 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • prEN 868-1-1992 Packaging materials for sterilization of wrapped goods; part 1: general requirements and requirements for the validation of packaging for terminally sterilized devices
  • EN ISO 28862:2023 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)
  • prEN 868-6-1992 Packaging materials for sterilization of wrapped goods; part 6: paper for the manufacture of packs for medical use for sterilization by ethylene oxide of irradiation; requirements and tests
  • EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling
  • EN 13430:2000 Packaging - Requirements for Packaging Recoverable by Material Recycling
  • EN 862:2005 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for nonpharmaceutical products
  • EN 862:1997 Packaging - Child-Resistant Packaging - Requirements and Testing Procedures for Non-Reclosable Packages for Non-Pharmaceutical Products
  • EN 862:2001 Packaging - Child-Resistant Packaging - Requirements and Testing Procedures for Non-Reclosable Packages for Non-Pharmaceutical Products
  • prEN 868-7-1992 Packaging materials for sterilization of wrapped goods; part 7: adhesive coated paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation; requirements and tests
  • EN ISO 14375:2023 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
  • prEN 868-8-1992 Packaging materials for sterilization of wrapped goods; part 8: re-usable sterilization containers; requirements and tests
  • EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for nonpharmaceutical products
  • EN 14375:2003 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • prEN 868-5-1992 Packaging materials for sterilization of wrapped goods; part 5: heat sealable pouches and reel material of paper and plastic film construction; requirements and tests
  • EN ISO/TS 16791:2015 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers
  • PD CEN/TR 13688:2008 Packaging - Material recycling - Report on requirements for substances and materials to prevent a sustained impediment to recycling [Superseded: DS DS/CEN/CR 13688]
  • PD CEN/TR 13695-2:2004 Packaging - Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging, and their release into the environment - Part 2: Requirements for measuring and verifying dangerous substances present in packa

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Pharmaceutical Packaging Material Requirements

  • GB/T 42894-2023 Emergency Medicine Packaging Requirements
  • GB/T 28837-2012(英文版) Requirement on services of quarantine treatments of wood packing material
  • GB/T 42089-2022 Child-resistant packaging—Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products

British Standards Institution (BSI), Pharmaceutical Packaging Material Requirements

  • BS ISO 28862:2018 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • BS EN ISO 15378:2015 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • BS EN ISO 15378:2011 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • BS EN ISO 28862:2023 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • BS 8404:2001 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for pharmaceutical products
  • BS EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling
  • BS EN 13430:2004(2009) Packaging - Requirements for packaging recoverable by material recycling
  • BS EN 862:2005 Packaging — Childresistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • BS EN 862:2006 Packaging. Child resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • BS EN 862:2016 Tracked Changes. Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • BS EN ISO 15378:2017 Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • 16/30347647 DC BS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • BS ISO 14375:2018 Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing
  • BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 11607-1:2010 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • PD CEN ISO/TS 16791:2020 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
  • BS PD ISO/TS 16791:2014 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
  • BS EN ISO 14375:2023 Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing

Inner Mongolia Provincial Standard of the People's Republic of China, Pharmaceutical Packaging Material Requirements

  • DB15/T 1174-2017 Pharmaceutical logistics refrigerated drug transport packaging requirements
  • DB15/T 1484-2018 Packaging requirements for refrigerated and frozen pharmaceutical logistics
  • DB15/T 2868-2023 Storage Requirements for Raw Materials and Packaging Materials of Fengzhen Mooncakes

RU-GOST R, Pharmaceutical Packaging Material Requirements

  • GOST R 53699-2009 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • GOST R ISO 15378-2017 Primery packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008 with reference to good manufacturing practice (GMP)
  • GOST 33524-2015 Resources saving. Packaging. Requirements for packaging recoverable by material recycling
  • GOST R 53742-2009 Resources saving. Packaging. Requirements for packaging recoverable by material recycling
  • GOST R ISO 15378-2014 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

IPC - Association Connecting Electronics Industries, Pharmaceutical Packaging Material Requirements

  • IPC 1758-2012 Declaration Requirements for Shipping@ Pack and Packing Materials

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Pharmaceutical Packaging Material Requirements

  • GB/T 34344-2017 General technical requirement of packaging materials for agricultural products logistics

German Institute for Standardization, Pharmaceutical Packaging Material Requirements

  • DIN 19302:2006 Packaging materials - Paper for general packaging purposes - Requirements, test method
  • DIN 19302:2006-02 Packaging materials - Paper for general packaging purposes - Requirements, test method
  • DIN EN ISO 15378:2007 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006); German and English version EN ISO 15378:2007
  • DIN EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011
  • DIN EN ISO 15378:2018-04 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
  • DIN EN 862:2016-09 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products; German version EN 862:2016 / Note: To be replaced by DIN EN ISO 28862 (2022-12).
  • DIN EN ISO 28862:2022-12 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018); German and English version prEN ISO 28862:2022 / Note: Date of issue 2022-11-04*Intended as replac...
  • DIN EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling; German version EN 13430:2004
  • DIN EN 13430:2004-10 Packaging - Requirements for packaging recoverable by material recycling; German version EN 13430:2004
  • DIN EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
  • DIN 55468-1:2021 Packaging materials - Corrugated board - Part 1: Requirements, testing
  • DIN 55468-1:2015 Packaging materials - Corrugated board - Part 1: Requirements, testing
  • DIN 55468-1:2014 Packaging materials - Corrugated board - Part 1: Requirements, testing
  • DIN 55468-1:2004 Packaging materials - Corrugated board - Part 1: Requirements, testing
  • DIN 55468-1:2021-01 Packaging materials - Corrugated board - Part 1: Requirements, testing
  • DIN EN 14375:2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing; German version EN 14375:2003
  • DIN 55428-1:1998 Packaging materials - Solid fibreboard - Part 1: Requirements, testing
  • DIN EN ISO 14375:2023-07 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018); German version EN ISO 14375:2023
  • DIN CEN ISO/TS 16791:2021-02 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020); German version CEN ISO/TS 16791:2020
  • DIN EN 14375 Berichtigung 1:2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing; German version EN 14375:2003, Corrigenda to DIN EN 14375:2004-02; German version EN 14375:2003/AC:2006
  • DIN 55468-2:2004 Packaging materials - Corrugated board - Part 2: Wet strength, requirements, testing

Professional Standard - Pharmaceutical Packaging, Pharmaceutical Packaging Material Requirements

  • YBB 0014-2002 Yaopinbaozhuangcailiao yu yaowu xiangrongxingshiyan zhidao yuanze Guidelines of evaluating compatibility between pharmaceutical packaging and pharmaceuticals
  • YBB 0014(02)-2002 Guidelines for Compatibility Testing of Drug Packaging Materials and Drugs (Trial)
  • YBB 0041-2004 Test methods for clean room to produce pharmaceutical packaging materials
  • YBB 00412004-2015 Test methods for clean rooms (areas) of pharmaceutical packaging material production plants

Danish Standards Foundation, Pharmaceutical Packaging Material Requirements

  • DS/EN 13430:2006 Packaging - Requirements for packaging recoverable by material recycling
  • DS/EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • DS/EN 862:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • DS/EN 14375:2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • DS/EN 14375:2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • DS/CEN/TR 13688:2008 Packaging - Material recycling - Report on requirements for substances and materials to prevent a sustained impediment to recycling

Lithuanian Standards Office , Pharmaceutical Packaging Material Requirements

  • LST EN 13430-2005 Packaging - Requirements for packaging recoverable by material recycling
  • LST EN 862-2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • LST EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
  • LST EN 14375-2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • LST EN 14375-2004/AC-2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing

AENOR, Pharmaceutical Packaging Material Requirements

  • UNE-EN 13430:2005 Packaging - Requirements for packaging recoverable by material recycling
  • UNE-CEN/TR 13688:2008 IN Packaging - Material recycling - Report on requirements for substances and materials to prevent a sustained impediment to recycling

Korean Agency for Technology and Standards (KATS), Pharmaceutical Packaging Material Requirements

  • KS T 5012-2020 Packaging — Complete, filled transport packages —Requirements of passive type packaging for temperature controlled transport of pharmaceuticals

CEN - European Committee for Standardization, Pharmaceutical Packaging Material Requirements

  • EN ISO 15378:2007 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000@ with reference to Good Manufacturing Practice (GMP)
  • EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015@ with reference to good manufacturing practice (GMP)

International Organization for Standardization (ISO), Pharmaceutical Packaging Material Requirements

  • ISO 15378:2006 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
  • ISO 28862:2018 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • ISO 14375:2018 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • ISO 5989:1995 Photography - Pre-packaged chemicals for the processing of silver halide based photographic materials - Vocabulary
  • ISO/TS 16791:2014 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers

Association Francaise de Normalisation, Pharmaceutical Packaging Material Requirements

  • NF S93-200:2008 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP).
  • NF S93-200:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP).
  • NF EN ISO 15378:2018 Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
  • NF EN ISO 28862:2023 Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques
  • NF EN 862:2016 Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques
  • NF S93-200*NF EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • NF H60-120*NF EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling.
  • NF H00-202*NF EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • NF EN 13430:2004 Emballage - Exigences relatives aux emballages valorisables par recyclage matière
  • NF H00-202:1997 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
  • NF H00-202:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
  • NF H00-204:2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing.
  • NF EN ISO 14375:2023 Emballages non refermables à l'épreuve des enfants pour produits pharmaceutiques - Exigences et essais
  • NF S98-052-1:2009 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
  • NF H00-204*NF EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • NF EN 14375:2016 Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais
  • NF S98-051-9:2009 Packaging materials for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods.
  • FD H60-121*FD CEN/TR 13688:2008 Packaging - Material recycling - Report on requirements for substances and materials to prevent a sustained impediment to recycling
  • NF H60-140*NF EN 13432:2000 Packaging - Requirements for packaging recoverable through compositing and biodegradation - Test scheme and evaluation criteria for the final acceptance of packaging.

中华全国供销合作总社, Pharmaceutical Packaging Material Requirements

  • GH/T 1340-2021 Technical requirements for processing cotton packaging materials

ES-UNE, Pharmaceutical Packaging Material Requirements

  • UNE-EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
  • UNE-EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
  • UNE-EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
  • UNE-CEN ISO/TS 16791:2020 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020) (Endorsed by Asociación Española de Normalización in November of 2020.)

Shanghai Provincial Standard of the People's Republic of China, Pharmaceutical Packaging Material Requirements

  • DB31/ 534-1996 Hygienic quality requirements for polyvinyl chloride resin used in food packaging materials

Professional Standard - Press and Publication, Pharmaceutical Packaging Material Requirements

  • CY/T 57-2009 Basic requirements for publication transportation packaging materials

Group Standards of the People's Republic of China, Pharmaceutical Packaging Material Requirements

  • T/CCAA 0022-2014 Food safety management system—Requirements for food packaging containers and artic1es product estab1ishments
  • T/HBFPIA 002-2023 General technical requirements for plastic lids for food packaging
  • T/CI 053-2022 Technical requirements for packaging of stamping raw materials of auto parts
  • T/CSX 005-2023 Variable QR code printing quality requirements for plastic packaging products

International Federation of Trucks and Engines, Pharmaceutical Packaging Material Requirements

Professional Standard - Environmental Protection, Pharmaceutical Packaging Material Requirements

  • HJ 209-2017 Technical requirements for environmental labeling products Plastic packaging products

PT-IPQ, Pharmaceutical Packaging Material Requirements

  • NP EN 862-2000 Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products

Standard Association of Australia (SAA), Pharmaceutical Packaging Material Requirements

HU-MSZT, Pharmaceutical Packaging Material Requirements

Professional Standard - Medicine, Pharmaceutical Packaging Material Requirements

  • YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
  • YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices.Part 1:Co-extrusion plastic films used for vacuum forming packaging.Requirements and test methods

国家药监局, Pharmaceutical Packaging Material Requirements

  • YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials

Hunan Provincial Standard of the People's Republic of China, Pharmaceutical Packaging Material Requirements

  • DB43/T 1593-2019 Safety technical requirements for packaging of chemical raw materials for fireworks and firecrackers

Hebei Provincial Standard of the People's Republic of China, Pharmaceutical Packaging Material Requirements

  • DB13/T 2472-2017 General technical requirements for plastic tools for disposable food packaging

IT-UNI, Pharmaceutical Packaging Material Requirements

  • UNI CEN ISO/TS 16791:2020 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers

ZA-SANS, Pharmaceutical Packaging Material Requirements

  • SANS 50868-2:2003 Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap - Requirements and test methods




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