ΕΛΟΤ EN ISO 15378 Ε3
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
ΕΛΟΤ EN ISO 15378 Ε3
Abstract
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.
Info
The standard has been withdrawn
Publication Date
2016-02-19
Withdrawal Date
2017-12-19
Greek Title
Υλικά πρωτογενούς συσκευασίας για ιατρικά είδη - Ειδικές απαιτήσεις για την εφαρμογή του ISO 9001:2008, με αναφορά στην Ορθή Βιομηχανική Πρακτική (GMP)
English Title
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
Standard Stage
Techincal Body
YReplaced by
ΕΛΟΤ EN ISO 15378 Ε4:2017Replaces
ΕΛΟΤ EN ISO 15378 E2:2012Related Documents
