ISO-15378 › Historical Revision Information
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

ISO-15378 - 1ST EDITION - SUPERSEDED
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


ISO 15378:2011 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.

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

ORDER

To find similar documents by classification:

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, health care management systems, etc.)

03.120.10 (Quality management and quality assurance)

11.040.01 (Medical equipment in general)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO 15378:2006

Revision Level

1ST EDITION

Status

Superseded

Publication Date

March 1, 2006

Committee Number

ISO/TC 76