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Norm
ÖNORM EN ISO 15378
Issue date: 2012 03 01
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging mat...
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Withdrawn
: 2016 03 15
Publisher:
Austrian Standards International
Format:
Digital | 77 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
This International Standard 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. In this International Standard the term if appropriate is used several times. When a requirement is qualified by this phrase, it is deemed to be appropriate unless the organization can document a justification otherwise.
ÖNORM EN ISO 15378
2018 04 01
Primary packaging materials for medicinal products - Particular requirements for the application of ...
Norm
ÖNORM EN ISO 15378
2016 03 15
Primary packaging materials for medicinal products - Particular requirements for the application of ...
Norm
ÖNORM EN ISO 15378
2012 03 01
Primary packaging materials for medicinal products - Particular requirements for the application of ...
Norm
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ÖNORM EN ISO 15378
2007 10 01
Primary packaging materials for medicinal products - Particular requirements for the application of ...
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ÖNORM EN ISO 15378
Issue date :
2016 03 15
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)