BAS EN ISO 15378:2013
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
General Information
Status: Withdrawn
No. of pages: 70
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 03.09.2013
Technical committee:
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15378:2011, identical
- ISO 15378:2011, identical