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Standards [CURRENT]

DIN EN ISO 15378
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); German version EN ISO 15378:2017

Title (German)

Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) (ISO 15378:2017); Deutsche Fassung EN ISO 15378:2017

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-01-06 AA - Quality management systems for primary packaging  

Responsible european committee

CEN/BT - BT Technical Board  

Responsible international committee

ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables  

Edition 2018-04
Original language German
Translation English
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Table of contents

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