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Draft standard [New]

DIN EN ISO 15378/A1
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

Title (German)

Primärpackmittel für Arzneimittel - Besondere Anforderungen für die Anwendung von ISO 9001:2015 entsprechend der Guten Herstellungspraxis (GMP) - Änderung 1: Ergänzung zu klimabezogenen Maßnahmen (ISO 15378:2017/Amd 1:2024); Deutsche und Englische Fassung EN ISO 15378:2017/prA1:2024

Responsible national committee

NA 176-04-04 AA - Packaging systems for loading and application of medical devices  

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 2024-05
Publication 2024-04-05
Public enquiry period until 2024-06-05
Original language German , English
Read draft and comment Order from DIN Media
Table of contents

Contact

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