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ISO 15378:2015

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) ISO 15378:2015

Publication date:   Oct 6, 2015

95.99   Withdrawal of Standard   Sep 14, 2017

General information

95.99   Withdrawal of Standard   Sep 14, 2017

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

03.100.70   Management systems | 11.040.01   Medical equipment in general

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Scope

ISO 15378:2015 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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15378:2011

NOW

WITHDRAWN
ISO 15378:2015
95.99 Withdrawal of Standard
Sep 14, 2017

REVISED BY

PUBLISHED
ISO 15378:2017




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