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SRPS EN ISO 15378:2008

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)

Dec 29, 2008
95.99   Withdrawal of Standard   Sep 30, 2015

General information

95.99     Sep 30, 2015

ISS

Z076

European Norm

03.120.10     11.040.01     03.100.70  

English  

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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WITHDRAWN
SRPS EN ISO 15378:2008
95.99 Withdrawal of Standard
Sep 30, 2015

REVISED BY

WITHDRAWN
SRPS EN ISO 15378:2015

Related project

Adopted from EN ISO 15378:2007

Adopted from ISO 15378:2006 IDENTICAL