ISO 15378:2015Withdrawn

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Articles d'emballage primaire pour médicaments — Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF)

This edition has been replaced by ISO 15378:2017.

Abstract / scope

ISO 15378:2015 specifies requirements 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 applicable to primary packaging materials.

Life cycle

Replaces

ISO 15378:2011WithdrawnPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)International Standard · Published 25 Oct 2011 · ISO/TC 76

Replaced by

ISO 15378:2017PublishedPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)International Standard · Published 14 Sep 2017 · ISO/TC 76