ISO 15378

ISO 15378 is a complete, integrated quality management system standard combining ISO 9001:2000 and Good Manufacturing Practices for Primary Pharmaceutical Packaging Materials. 

In addition to the complete requirements of ISO 9001:2000, ISO 15378 contains relevant GMPs for the design, manufacture and supply of packaging materials for medicinal products. 

These GMP’s are based on a scientific, practical and cost effective balance, agreed following wide consultation and comment. 

In line with current developments world-wide, the standard also contains guidance annexes on Risk Management and Validation. 

The standard was published in 2006 as a full ISO, European Norme (EN) and British Standard (BS) and is an invaluable tool for Purchasing, Packaging Development, Supply Chain Management, Quality Assurance and Control and, more importantly, suppliers! 

ISO 15378 can be used for quality improvement, training, auditing and certification purposes. Accredited Certification can lead to formal recognition and Certified Supplier status. ISO 15378 is available from ISO and other registered sources.  

Updates of the standard are currently being discussed and a further potential development is to extend the standard to include secondary packaging materials.  

We acknowledge the work of the members of the UK ISO 15378 team:

David Abraham Roy Evans Jill Jenkins Ashok Chand
Tony Harper Mike Shorten Liz Davies Bill Hewlett
Steve Taylor Antoinette Devine Afshin Hosseiny John Turner