ISO 15378:2011

$50.70

Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

Published By	Publication Date	Number of Pages
ISO	2011-11	78

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Categories: 03.100.70 - Management systems, 11.040.01 - Medical equipment in general, ISO

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Description

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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2011-11
Pages Count	78
Language	English
Edition	2
File Size	849.9 KB
ICS Codes	03.100.70 - Management systems 11.040.01 - Medical equipment in general

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ISO 15378:2011

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