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ISO 15378:2006

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

Mar 1, 2006
95.99 Withdrawal of Standard   Oct 25, 2011

General information

95.99     Oct 25, 2011

ISO

ISO/TC 76

International Standard

03.100.70     11.040.01  

English   French  

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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WITHDRAWN
ISO 15378:2006
95.99 Withdrawal of Standard
Oct 25, 2011

REVISED BY

WITHDRAWN
ISO 15378:2011

National adoptions

SSH ISO 15378:2007  
DPS

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

95.99 Withdrawal of Standard

DPS/KT 1 more