ISO 15378:2006

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

Standard Details

ISO 15378:2006 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.

ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

General Information

Status : WITHDRAWN

Standard Type: Main

Document No: ISO 15378:2006

Document Year: 2006

Pages: 59

Edition: 1

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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