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SSH 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)

Jan 1, 2007
95.99 Withdrawal of Standard   Nov 2, 2012

General information

95.99     Nov 2, 2012

DPS

DPS/KT 1

International Standard

03.100.70     11.040.01     03.120.10  

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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WITHDRAWN
SSH ISO 15378:2007
95.99 Withdrawal of Standard
Nov 2, 2012

REVISED BY

WITHDRAWN
SSH EN ISO 15378:2011

PUBLISHED
SSH ISO 15378:2017

Related project

Adopted from ISO 15378:2006