BAS EN ISO 15378:2013
Materijali za primarno pakovanje medicinskih proizvoda – Posebni zahtjevi za primjenu ISO 9001 :2008, s upućivanjem na dobru proizvodnu praksu
Опште информације
Статус: Повучен
Број страна: 70
Језик: Енглески
Издање: 2.
Метода усвајања: Proglašavanje
Датум објаве: 03.09.2013
Технички комитет:
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Апстракт
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.
Животни циклус
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Изворни документ и степен усаглашености
- EN ISO 15378:2011, идентичан
- ISO 15378:2011, идентичан