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UNI EN ISO 15378 : 2018

Current
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)
Published date

03-01-2018

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.

Committee
CT 44
DocumentType
Standard
ProductNote
Page count for Italian version of this standard is 86.
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

Standards Relationship
ISO 15378:2017 Identical
EN ISO 15378:2017 Identical

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