BAS EN ISO 15378:2008
Materijali za primarno pakovanje medicinskih proizvoda – Posebni zahtjevi za primjenu ISO 9001 :2000, s upućivanjem na dobru proizvodnu praksu (GMP)
Opšte informacije
Status: Povučen
Broj strana: 77
Jezik: Engleski
Izdanje: 1.
Metoda usvajanja: Proglašavanje
Datum objave: 23.12.2008
Tehnički komitet:
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Apstrakt
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.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 15378:2007, identičan
- ISO 15378:2006, identičan