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)

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

  • Current status : Withdrawn
    Publication date : 2015-10
  • Edition : 3
  • :
    ISO/TC 76
    Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • 03.100.70
    Management systems
    11.040.01
    Medical equipment in general

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