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    This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations
    ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and. b) aims to enhance customer satisfaction through the effective
    A certificate to ISO 15378, with its holistic approach to GMP and quality require- ments, is recognized throughout the world. It provides manufacturers of primary packaging materials with a suitable qualification for customer approval – as well as improving the organization’s image in the eyes of the authorities. ISO 15378
    La certification ISO 15378 permet a une entreprise de demontrer son engagement en matiere de securite des emballages de produ- its pharmaceutiques. Elle repond aux exigences de l’ISO 9001 tout en prenant en consideration les Bonnes Pratiques de Fabri- cation (BPF). Cette norme va ainsi permettre de garantir la
    ISO 2011. INTERNATIONAL. STANDARD. ISO. 15378. Second edition. 2011-11-01. Primary packaging materials for medicinal products — Particular requirements for the application of. ISO 9001:2008, with reference to Good. Manufacturing Practice (GMP). Articles de conditionnement primaire pour medicaments —
    ISO 15378:2015 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

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