Pharmaceutical Packaging Material Requirements

Pharmaceutical Packaging Material Requirements, Total:150 items.

The international standard classification for "Pharmaceutical Packaging Material Requirements" includes: Packaging and distribution of goods in general , Packaging materials and accessories , Medical Sciences and health care facilities in general , Farming and forestry , Aids for disabled or handicapped persons .

The Chinese standard classification for "Pharmaceutical Packaging Material Requirements" includes: Marking, packaging, transport and storage in general , Marking, packaing, transport and storage , Standardization, quality management , Packaging material and container , Extracorporeal circulation, artificial organ and prosthesis device .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 42894-2023 Packaging requirement for emergency medicines and equipments
GB/T 28837-2012(英文版) Requirement on services of quarantine treatments of wood packing material

Inner Mongolia Provincial Standard of the People's Republic of China

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

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

GB/T 34344-2017 General technical requirement of packaging materialsfor agricultural products logistics

Professional Standard - Pharmaceutical Packaging

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

未注明发布机构

DIN EN ISO 15378 E:2014-04 For the special requirements of ISO 9001:2015 for the application of inner packaging materials of pharmaceutical products, please refer to the Good Manufacturing Practice (Draft)
DIN 6120 E:2018-08 Marking of packaging and packaging materials - Plastics packaging and packaging materials
DIN 19302:1995 Packaging materials - Paper for general packaging purposes - Requirements, test method
DIN EN ISO 15378:2016 Inner packaging materials for pharmaceutical products apply the special requirements of ISO 9001 and refer to Good Manufacturing Practice (GMP)
DIN EN ISO 15378 E:2016-11 For the special requirements of ISO 9001:2015 for the application of inner packaging materials of pharmaceutical products, please refer to the Good Manufacturing Practice (Draft)
DIN EN 13430:2000 Packaging - Requirements for packaging recoverable by material recycling

中华全国供销合作总社

GH/T 1340-2021 Technical requirements for cotton packing material processing

Shanghai Provincial Standard of the People's Republic of China

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

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4723-2024 General requirements for packaging, storage and transportation of graphene materials

Professional Standard - Press and Publication

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

Group Standards of the People's Republic of China

T/HBFPIA 002-2023 General technical requirements for plastic lids for food packaging
T/CCAA 0022-2014 Food safety management system—Requirements for food packaging containers and artic1es product estab1ishments

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 37105-2018 Packaging—Braille on packaging for medicinal products

Professional Standard - Environmental Protection

HJ 209-2017 Technical requirement for environmental labeling products Plastic packaging products

International Organization for Standardization (ISO)

ISO 15378:2017/Amd 1:2024 Primary packaging materials for medicinal products
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 17351:2013 Packaging - Braille on packaging for medicinal products
ISO 16103:2005 Packaging - Transport packaging for dangerous goods - Recycled plastics material

British Standards Institution (BSI)

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 862:2016 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
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 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)
BS EN 862:2005 Packaging — Childresistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 13430:2004(2009) Packaging - Requirements for packaging recoverable by material recycling
BS EN 862:2006 Packaging. Child resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling
BS EN ISO 16103:2006 Packaging - Transport packages for dangerous goods - Recycled plastics material
BS EN 15823:2010 Packaging - Braille on packaging for medicinal products

RU-GOST R

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)

IPC - Association Connecting Electronics Industries

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

European Committee for Standardization (CEN)

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)
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 868-1-1992 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 862:2001 Packaging - Child-Resistant Packaging - Requirements and Testing Procedures for Non-Reclosable Packages for Non-Pharmaceutical Products
EN 862:2005 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for nonpharmaceutical products
EN 13430:2000 Packaging - Requirements for Packaging Recoverable by Material Recycling
EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling
EN 862:1997 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)

German Institute for Standardization

DIN 19302:2006 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 19302:2006-02 Packaging materials - Paper for general packaging purposes - Requirements, test method
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 13430:2004-10 Packaging - Requirements for packaging recoverable by material recycling; German version EN 13430:2004
DIN EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling; German version EN 13430:2004
DIN 6120:2019-03 Marking of packaging and packaging materials - Plastics packaging and packaging materials
DIN 6120:2019 Marking of packaging and packaging materials - Plastics packaging and packaging materials
DIN EN ISO 28862:2024-01 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018); German version EN ISO 28862:2023
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)

SCC

BS EN 13430:2000 Packaging. Requirements for packaging recoverable by material recycling
NS-EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling
DANSK DS/EN 13430:2006 Packaging - Requirements for packaging recoverable by material recycling
NS-EN 862:2001 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
NS-EN 13430:2000 Packaging — Requirements for packaging recoverable by material recycling
DANSK DS/ISO 28862:2022 Packaging – Child-resistant packaging – Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 862:2001 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
DANSK DS/EN 862:2016 Packaging – Child-resistant packaging – Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
UNE-EN 862:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 862:1997 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
NS-EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
UNE-EN ISO 15378:2008 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)
07/30160645 DC BS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
NS-EN 862:2005 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
NS-EN 862:1997 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS 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)
NS-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)
BS 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)
DANSK DS/EN ISO 16103:2005 Packaging - Transport packages for dangerous goods - Recycled plastics material
NS-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) (ISO 15378:2011)
NS-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) (ISO 15378:2017)
AENOR 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)
DIN EN ISO 28862:2024 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018); German version EN ISO 28862:2023
NS-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) (ISO 15378:2015)
NS-EN ISO 28862:2023 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)
DANSK DS/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) (ISO 15378:2017)
BS 868-5:1997 Packaging Materials and Systems for Sterilization of Wrapped Goods - Part 5: Heat Sealable Pouches and Reel Material of Paper and Plastic Film Construction - Requirements and Tests
NS 1156:1971 Corrugated cardboard materials for packages, agricultural use — Quality requirements
UNE-EN 14375:2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
NS-EN 14375:2003 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
DANSK DS/EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products – Requirements and testing
DIN EN 862 E:2015 Draft Document - Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceuticalproducts; German and English version FprEN 862:2015
DANSK DS/ISO 14375:2022 Child-resistant non-reclosable packaging for pharmaceutical products – Requirements and testing

Korean Agency for Technology and Standards (KATS)

KS T 5012-2020 Packaging — Complete, filled transport packages —Requirements of passive type packaging for temperature controlled transport of pharmaceuticals
KS A 1207-1990 PACKAGING AND PACKING OF medicine (Tablets)
KS T ISO 16103:2013 Packaging ― Transport packaging for dangerous goods ― Recycled plastics material
KS T ISO 16103:2008 Packaging-Transport packaging for dangerous goods-Recycled plastics material

AENOR

UNE-EN 13430:2005 Packaging - Requirements for packaging recoverable by material recycling

Lithuanian Standards Office

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)

CEN - European Committee for Standardization

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)
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)

Danish Standards Foundation

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 ISO 16103:2005 Packaging - Transport packages for dangerous goods - Recycled plastics material
DS/EN 862:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products

Association Francaise de Normalisation

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 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 EN ISO 15378:2018 Primary packaging items for medicinal products - Particular requirements for the application of ISO 9001:2015 taking into account Good Manufacturing Practices (GMP)
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 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 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 H00-202*NF EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
NF EN ISO 16103:2005 Packaging - Transport packaging for dangerous goods - Recycled plastic materials
NF H60-120*NF EN 13430:2004 Packaging - Requirements for packaging recoverable by material recycling.
NF H00-202:1997 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
NF H00-106*NF EN ISO 16103:2005 Packaging - Transport packages for dangerous goods - Recycled plastics material
NF EN ISO 17351:2014 Emballage - Braille sur les emballages destinés aux médicaments
NF EN 13430:2004 Emballage - Exigences relatives aux emballages valorisables par recyclage matière

GSO

BH GSO 1863:2022 Food packages - Part 2: Plastic package – General requirements
GSO 1863:2021 Food packages - Part 2: Plastic package – General requirements
GSO ISO 16103:2007 Packaging - Transport packaging for dangerous goods – Recycled plastics material
GSO ISO 17351:2017 Packaging -- Braille on packaging for medicinal products
OS GSO ISO 17351:2017 Packaging -- Braille on packaging for medicinal products

ES-UNE

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

HU-MSZT

MSZ 5692-1982 Medicine package

IN-BIS

IS 8190 Pt.1-1988-1 Pesticide Packaging Requirements Part 1 Solid Pesticides
IS 8190 Pt.1-1988 Pesticide Packaging Requirements Part 1 Solid Pesticides
IS 8190 Pt.2-1988 Pesticide Packaging Requirements Part 2 Liquid Pesticides
IS 8190 Pt.3-1979 Pesticide Packaging Requirements Part III Household Pesticides

CZ-CSN

CSN 65 0509-1983 Pesticides. equlrements for packing arking and transport

NL-NEN

LUN 7101b-1970 Abrasive packaging requirements
LUN 7001a-1962 Abrasive packaging requirements

AT-ON

ONORM A 5510-1981 Sensory testing of packaging materials and packages for food products

International Federation of Trucks and Engines

NAVISTAR MPAPS G-5 PART I-2014 VOID - Paint Material and Finished Product Requirements (Includes Appendix)

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