DIN EN ISO 15378:2016-11
Superseded Draft standard
Historical

DIN EN ISO 15378:2016-11

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016
Most recent standard

Summary

This 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. This standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

Notes

Prévu pour remplacer DIN EN ISO 15378 (2016-03).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 11/01/2016
Cancellation Date 04/01/2018
Page Count 183
EAN ---
ISBN ---
Weight (in grams) ---
No products.

Previous versions

DIN EN ISO 15378/A1:2024-11

DIN EN ISO 15378/A1:2024-11

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 15378:2017/Amd 1:2024); German version EN ISO 15378:2017/A1:2024
01/11/2024
Active
Most Recent
DIN EN ISO 15378/A1:2024-05

DIN EN ISO 15378/A1:2024-05

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 15378:2017/Amd 1:2024); German and English version EN ISO 15378:2017/prA1:2024

Traduction automatique de l'anglais :
Matériaux d'emballage primaire pour médicaments - Exigences particulières pour l'application de la norme ISO 9001:2015, en référence aux bonnes pratiques de fabrication (BPF) - Amendement 1 : Changements liés à l'action climatique (ISO 15378:2017/Amd 1:2024) ; Version allemande et anglaise EN ISO 15378:2017/prA1:2024
01/05/2024
Superseded
Historical
DIN EN ISO 15378:2018-04

DIN EN ISO 15378:2018-04

Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2017); Version allemande EN ISO 15378:2017
01/04/2018
Active , Modified
Most Recent
DIN EN ISO 15378:2016-11

DIN EN ISO 15378:2016-11

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016
01/11/2016
Superseded
Historical
DIN EN ISO 15378:2016-03

DIN EN ISO 15378:2016-03

Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2015); Version allemande EN ISO 15378:2015
01/03/2016
Superseded
Historical
DIN EN ISO 15378:2014-04

DIN EN ISO 15378:2014-04

Articles de conditionnement primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO/DIS 15378:2014); Version allemande prEN ISO 15378:2014
01/04/2014
Superseded
Historical
DIN EN ISO 15378:2012-02

DIN EN ISO 15378:2012-02

Articles de conditionnement primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2008 prenant en considération les Bonnes Pratiques de Fabrication (BPF) (ISO 15378:2011); Version allemande EN ISO 15378:2011
01/02/2012
Superseded
Historical
DIN EN ISO 15378:2011-07

DIN EN ISO 15378:2011-07

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO/FDIS 15378:2011); German version FprEN ISO 15378:2011
01/07/2011
Superseded
Historical
DIN EN ISO 15378:2007-10

DIN EN ISO 15378:2007-10

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2006); German and English version EN ISO 15378:2007
01/10/2007
Superseded
Historical
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