ISO 15378 - A new GMP standard for Pharmaceutical Packaging Materials

What is ISO 15378?

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

Initially conceived for glass and then expanded to cover all primary packaging materials for pharmaceuticals, the next development is to extend the standard to include secondary packaging materials.

In addition to the complete requirements of ISO 9001:2000, ISO 15378 contains relevant GMP's 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.

Thanks must be given to 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

The standard was published in 2006 as a full ISO, European Norme (EN) and British Standard (BS) and will be 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.