ISO 15378:2017
Current
Current
The latest, up-to-date edition.
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Amended by
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
14-09-2017
ISO 15378:2017 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.
| DevelopmentNote |
Supersedes ISO/DIS 15378. (09/2017)
|
| DocumentType |
Standard
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| Pages |
79
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
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| Supersedes |
| Standards | Relationship |
| SS-EN ISO 15378:2017 | Identical |
| I.S. EN ISO 15378:2015 | Identical |
| UNI EN ISO 15378 : 2011 | Identical |
| I.S. EN ISO 15378:2017 | Identical |
| SN EN ISO 15378:2018 | Identical |
| UNI EN ISO 15378 : 2018 | Identical |
| BS EN ISO 15378:2017 | Identical |
| NEN EN ISO 15378 : 2017 | Identical |
| DIN EN ISO 15378:2016-03 | Identical |
| UNE-EN ISO 15378:2018 | Identical |
| ONORM EN ISO 15378 : 2018 | Identical |
| NF EN ISO 15378 : 2018 | Identical |
| PN EN ISO 15378 : 2018 | Identical |
| EN ISO 15378:2017 | Identical |
| DIN EN ISO 15378:2018-04 | Identical |
| IS/ISO 15378 : 2017 | Identical |
| NF ISO 15378 : 2006 | Identical |
| UNE-EN ISO 15378:2016 | Identical |
| BS ISO 15378 : 2006 AMD 17315 | Identical |
| NEN ISO 15378 : 2006 | Identical |
| NS EN ISO 15378 : 2017 | Identical |
| GOST R ISO 15378 : 2014 | Identical |
| DIN ISO 15378:2006-06 | Identical |
| NBN EN ISO 15378 : 2011 | Identical |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| 10/30212297 DC : 0 | BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES |
| BS ISO 11040-3:2012 | Prefilled syringes Seals for dental local anaesthetic cartridges |
| UNE-EN ISO 8362-5:2016 | Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) |
| BS ISO 13926-3:2012 | Pen systems Seals for pen-injectors for medical use |
| UNE-ISO 37500:2016 | Guidance on outsourcing |
| DIN ISO 8536-6:2017-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| DIN ISO 8536-6:2012-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
| 10/30218554 DC : 0 | BS ISO 13926-3 - PEN SYSTEMS - PART 3: SEALS FOR PEN-INJECTORS FOR MEDICAL USE |
| PLUS 9001 (5th ed. pub. 2017) | The ISO 9000 essentials: A practical handbook for implementing the ISO 9000 family of standards |
| DIN EN ISO 8362-5 E : 2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| BS ISO 11040-2:2011 | Prefilled syringes Plunger stoppers for dental local anaesthetic cartridges |
| BS ISO 13926-2:2017 | Pen systems Plunger stoppers for pen-injectors for medical use |
| 10/30216808 DC : 0 | BS ISO 11040-3 - PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES |
| 17/30357741 DC : 0 | BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| BS ISO 11040-5:2012 | Prefilled syringes Plunger stoppers for injectables |
| DIN ISO 11040-4 E : 2017 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| BS ISO 14470:2011 | Food irradiation. Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food |
| 17/30349163 DC : 0 | BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING |
| UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| ISO 37500:2014 | Guidance on outsourcing |
| I.S. EN ISO 8536-2:2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| BS ISO 11040-6:2012 | Prefilled syringes Plastic barrels for injectables |
| DIN ISO 37500 E : 2015 | GUIDANCE ON OUTSOURCING (ISO 37500:2014) |
| DIN ISO 11040-2 E : 2012 | PREFILLED SYRINGES - PART 2: PLUNGER STOPPERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-2:2011) |
| 13/30254718 DC : 0 | BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| BS ISO 37500:2014 | Guidance on outsourcing |
| DIN ISO 11040-5:2013-12 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| BS EN ISO 8362-5:2016 | Injection containers and accessories Freeze drying closures for injection vials |
| UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| ISO 14470:2011 | Food irradiation — Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| BS EN 30-1-2:2012 | Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills |
| EN ISO 8362-2:2015 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| UNI EN ISO 8536-2 : 2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| DIN ISO 37500:2015-08 | GUIDANCE ON OUTSOURCING (ISO 37500:2014) |
| DIN ISO 8362-5:2011-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| 17/30353012 DC : 0 | BS ISO 13926-2 - PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE |
| BS ISO 11040-7:2015 | Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| 14/30304354 DC : 0 | BS EN ISO 8362-5 - INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| BS ISO 11040-4:2015 | Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| 13/30273499 DC : 0 | BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| BS EN ISO 8362-2:2015 | Injection containers and accessories Closures for injection vials |
| DIN EN ISO 8362-5:2016-07 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| 07/30145258 DC : 0 | BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
| DIN ISO 11040-5 E : 2013 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| I.S. EN ISO 8362-5:2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| ISO 11040-3:2012 | Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges |
| ISO 13926-3:2012 | Pen systems Part 3: Seals for pen-injectors for medical use |
| ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
| ISO 13926-2:2017 | Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use |
| I.S. EN ISO 8362-2:2015 | INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION VIALS (ISO 8362-2:2015) |
| ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
| ISO 8362-5:2016 | Injection containers and accessories Part 5: Freeze drying closures for injection vials |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| EN 30-1-2:2012 | Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills |
| EN ISO 8362-5:2016 | Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) |
| EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
| DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| DIN ISO 11040-2:2012-10 | Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges (ISO 11040-2:2011) |
| BS ISO 8536-6:2016 | Infusion equipment for medical use Freeze drying closures for infusion bottles |
| ISO 11040-6:2012 | Prefilled syringes Part 6: Plastic barrels for injectables |
| DIN ISO 11040-4:2007-10 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| 14/30301958 DC : 0 | BS EN ISO 8362-2 - INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION |
| ISO 11040-4:2015 | Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 11040-7:2015 | Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling |
| I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
| DIN EN ISO 8536-2:2010-08 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| DIN ISO 11040-4:2017-07 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| DIN ISO 13926-2:2012-09 | PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE (ISO 13926-2:2011) |
| ISO 10001:2007 | Quality management Customer satisfaction Guidelines for codes of conduct for organizations |
| IEC 61025:2006 | Fault tree analysis (FTA) |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 10015:1999 | Quality management Guidelines for training |
| ISO 14644-8:2013 | Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC) |
| ISO 14698-2:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data |
| ISO/TR 10017:2003 | Guidance on statistical techniques for ISO 9001:2000 |
| ISO 11135:2014 | Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 60812:2006 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| ISO 14644-2:2015 | Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 31000:2009 | Risk management Principles and guidelines |
| IEC 61160:2005 | Design review |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| AS ISO 20387:2020 | Biotechnology - Biobanking - General requirements for biobanking |
| ISO 14644-5:2004 | Cleanrooms and associated controlled environments — Part 5: Operations |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 10019:2005 | Guidelines for the selection of quality management system consultants and use of their services |
| ISO 10004:2012 | Quality management Customer satisfaction Guidelines for monitoring and measuring |
| ISO 10014:2006 | Quality management Guidelines for realizing financial and economic benefits |
| ISO 10005:2005 | Quality management systems Guidelines for quality plans |
| ISO 10008:2013 | Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions |
| ISO 10003:2007 | Quality management Customer satisfaction Guidelines for dispute resolution external to organizations |
| ISO 10006:2003 | Quality management systems Guidelines for quality management in projects |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods |
| ISO 10018:2012 | Quality management Guidelines on people involvement and competence |
| ISO 10002:2014 | Quality management Customer satisfaction Guidelines for complaints handling in organizations |
| ASTM E 2500 : 2013 : REDLINE | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ISO 14644-3:2005 | Cleanrooms and associated controlled environments Part 3: Test methods |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO/IEC Guide 73:2002 | Risk management Vocabulary Guidelines for use in standards |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO/TR 10013:2001 | Guidelines for quality management system documentation |
| IEC 60300-1:2014 | Dependability management - Part 1: Guidance for management and application |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 14001:2015 | Environmental management systems — Requirements with guidance for use |
| ISO 14644-7:2004 | Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 37500:2014 | Guidance on outsourcing |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14644-4:2001 | Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up |
| ISO/IEC Guide 2:2004 | Standardization and related activities General vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 10007:2017 | Quality management — Guidelines for configuration management |
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