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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)

Publication date:   Jan 18, 2016

General information

99.60 Withdrawal effective   Oct 25, 2017

CEN

CEN/BT

European Norm

03.100.70   Management systems | 11.040.01   Medical equipment in general

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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

PREVIOUSLY

WITHDRAWN
EN ISO 15378:2011

NOW

WITHDRAWN
EN ISO 15378:2015
99.60 Withdrawal effective
Oct 25, 2017

REVISED BY

PUBLISHED
EN ISO 15378:2017