Quality Management System
Quality management system has being implemented to cover all Innovation, Bioproduction and Translational Research activities performed within the framework of the UMR1089 research projects, as well as the production activities and studies performed by the platforms; the CPV Translational Vector Core (CPV), the Gene Therapy Immunology platform (GTI) and the Pre-clinical Analytical Core platform (PAC). This quality management system is approved by LRQA for its compliance with the requirements of the international standard ISO 9001:2015 (Certificate_ISO9001_UMR1089).
In addition to the requirements of the standard, other recommendations and requirements specific to platform activities are taken into account, for example
- the requirements of GMP(1) as well as the guidelines applicable to ATMP Advanced Therapy Medicinal Products and other ICH recommendations as part of the translational projects conducted by the CPV platform;
- GcLP standards (2), as part of studies conducted by the GTI platform.
ATMP : Advanced Therapy Medicinal Products
GcLP : Good clinical Laboratory Practice
GMP : Good Manufacturing Practice
ICH : International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
EMA : GMP Eudralex Vol. 4 Part I
EMA : ATMP Advanced Therapy Medicinal Products – EMEA Eudralex Vol. 4 Part IV
