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)

Publication date: 6 tet 2015

95.99 Withdrawal of Standard 14 sht 2017

General information

Current stage: 95.99 Effective date: 14 sht 2017

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 03.100.70 11.040.01

Gjuha: anglisht frëngjisht

Buying

Statusi: Shfuqizuar

PDF - 7 350 Lekë

Paper - 7 350 Lekë

CD - 7 350 Lekë

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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WITHDRAWN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WITHDRAWN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
14 sht 2017

REVISED BY

PUBLISHED
ISO 15378:2017