Standard

NS-EN ISO 15378:2011

Apr 2012 Withdrawn

Note: This standard has a new edition: NS-EN ISO 15378:2017

Corrigenda and amendments are bought separately.

Language English

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Abstract

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.

Document information

Standard from SN
Published: 1 April 2012
Withdrawn: 1 February 2016
Edition: 2011-11
Version: 1
Document type: NAT
ISBN:

ICS 03.100.70
ICS 03.120.10
ICS 11.040.01
National Committee CEN/BT

Product Relations

Replaced by: NS-EN ISO 15378:2015
Replaces: NS-EN ISO 15378:2007
Adopted from: EN ISO 15378:2011 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 15378:2007
Current product

Withdrawn

NS-EN ISO 15378:2011
Replaced by

Withdrawn

NS-EN ISO 15378:2015

NS-EN ISO 15378:2011

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NS-EN ISO 15378:2017

NS-EN ISO 15378:2015