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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)
25. 10. 2011.
95.99   Povučen   6. 10. 2015.

Опште информације

95.99     6. 10. 2015.

ISO

ISO/TC 76

Međunarodni standard

03.100.70     11.040.01  

engleski   francuski  

Kupovina

Povučen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15378:2006

TRENUTNO

POVUČEN
ISO 15378:2011
95.99 Povučen
6. 10. 2015.

REVIDIRAN OD

POVUČEN
ISO 15378:2015

Nacionalna preuzimanja

SRPS EN ISO 15378:2015  
ISS

Materijali za primarno pakovanje medicinskih proizvoda — Posebni zahtevi za primenu ISO 9001:2008, sa posebnim osvrtom na dobru proizvođačku praksu (GPM)

95.99   Povučen

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