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)

Datum objavljivanja: 6. 10. 2015.

95.99 Povučen 14. 9. 2017.

Опште информације

Trenutna faza: 95.99 Effective date: 14. 9. 2017.

Inicijator: ISO

Pripada: ISO/TC 76

Vrsta: Međunarodni standard

ICS: 03.100.70 11.040.01

Jezik: engleski francuski

Kupovina

Status: Povučen

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Jezik

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15378:2011

TRENUTNO

POVUČEN
ISO 15378:2015
95.99 Povučen
14. 9. 2017.

REVIDIRAN OD

OBJAVLJEN
ISO 15378:2017