SUCCESSFUL ISO 15378 CERTIFICATION

For further information, visit www.audiciaux.fr, www.scobex-rgpd-dpo.fr and www.dpo-externe-rgpd-france.fr. In a sector where the quality of packaging directly affects the safety of medicines and patient confidence, the ISO 15378 standard is the essential benchmark. Combining the requirements of ISO 9001 and Good Manufacturing Practices (GMP), it provides a framework for the production of primary pharmaceutical packaging. This practical guide provides step-by-step support for organisations in their approach: initial diagnosis, process implementation, traceability control, supplier management and audit preparation. Illustrated with tools, models and case studies, it is a comprehensive operational manual for successful.