ISO-15378 › Historical Revision Information
Amendment 1: Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) - Amendment 1: Climate action changes

ISO-15378 - FOR 4TH EDITION AMENDMENT 1 SEE - CURRENT
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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.

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Document Number

ISO-15378

Revision Level

FOR 4TH EDITION AMENDMENT 1 SEE

Status

Current

Publication Date

Feb. 1, 2024

Committee Number

ISO/TC 76