UNI EN ISO 15378 : 2018
Current
The latest, up-to-date edition.
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
01-03-2018
In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which meet customer requirements, including regulatory requirements and International Standards.
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