EN ISO 15378:2007

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006)

Publication date:   Nov 30, 2007

General information

99.60 Withdrawal effective   Nov 1, 2011

CEN

CEN/BT

European Norm

03.100.70   Management systems | 11.040.01   Medical equipment in general

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Scope

ISO 15378:2006 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.
ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Life cycle

NOW

WITHDRAWN
EN ISO 15378:2007
99.60 Withdrawal effective
Nov 1, 2011

REVISED BY

WITHDRAWN
EN ISO 15378:2011

Relations

Adopted from ISO 15378:2006 IDENTICAL