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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)

Standard Details

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 StandardDetails applicable to primary packaging materials.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 15378:2015
Document Year: 2015
Pages: 63
Edition: 3
  • Section Volume:
  • ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • ICS:
  • 03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, hea
  • 11.040.01 Medical equipment in general

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WITHDRAWN
ISO 15378:2015
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