ISO 15378:2015 PDF
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
Title (English):
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)
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 63
- Publication date:
- October 6, 2015
- Edition:
- ISO IS 15378 edition 3 version 1
- ICS:
- 03.100.70
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- SKU
- ISO 15378:2015
