DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
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
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
Responsible international committee
ISO/TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables