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SSH EN ISO 15378:2011

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)

Oct 15, 2012
95.99 Withdrawal of Standard   Oct 5, 2016

General information

95.99     Oct 5, 2016

DPS

DPS/KT 1

European Norm

03.100.70     11.040.01     03.120.10  

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Scope

ISO 15378:2011 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 15378:2011 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

PREVIOUSLY

WITHDRAWN
SSH ISO 15378:2007

NOW

WITHDRAWN
SSH EN ISO 15378:2011
95.99 Withdrawal of Standard
Oct 5, 2016

Related project

Adopted from EN ISO 15378:2011