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Norm
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)
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Withdrawn
: 2018 04 01
Publisher:
Austrian Standards International
Format:
Digital | 82 Pages
Language:
German
| English
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.
This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
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
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ÖNORM EN ISO 15378
2012 03 01
Primary packaging materials for medicinal products - Particular requirements for the application of ...
Norm
ÖNORM EN ISO 15378
2007 10 01
Primary packaging materials for medicinal products - Particular requirements for the application of ...
Norm
Norm
ISO 9001:2008
Issue date :
2008 11 13
Quality management systems — Requirements (Corrected version 2009-07)
Norm
ISO 14698-1:2003
Issue date :
2003 09 17
Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods
Norm
ISO 14698-2:2003
Issue date :
2003 10 10
Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
Norm
ÖNORM EN ISO 15378
Issue date :
2018 04 01
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Norm
ISO 15378:2015
Issue date :
2015 10 06
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)