Superseded Standard
Historical

NBN EN 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) (ISO 15378:2011)

Summary

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.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 12/14/2011
Cancellation Date 05/31/2012
Page Count 88
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No products.