Reference number
ISO 15378:2015
© ISO 2025
ISO 15378:2015
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Edition 3
2015-10
Withdrawn
Withdrawn (Edition 3, 2015)

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.

General information

  • Status
     : Withdrawn
    Publication date
     : 2015-10
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 3
    Number of pages
     : 63
  • Technical Committee :
    ISO/TC 76
  • RSS updates

Life cycle

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