Quality and regulatory affairs

We work for a high quality management of samples and products by applying the main quality standards adapted or dedicated to our activities.

• ISO 9001 and ISO 20387 certification
• Application of good pharmaceutical practices: GMP, GCP, GCLP and GDP
• Qualification of cold storage units in accordance with the FD X15-140 standard
• Software validation in accordance with EU GMP Annex 11 and FDA 21 CFR Part 11

In addition to the application of these standards and certifications, Cryoport Systems France has the following ANSM authorisations:

• “MIA_Manufacturing_and_Importation_Authorization”: this authorization covers the following activities on PDC site: EU Batch certification, Importation, Storage and Secondary packaging for clinical and commercial products of the following types: Immunological products, Cell Therapy products, Gene therapy products, Biotechnology products and Tissue engineered products.
• “Cell_Therapy_Product_Conservation_Authorization”: this authorization, for PDC site, covers the storage activity of human cell therapy product which have been obtained without significant transformation meaning cells for grafts like hematopoietic stem cells. This authorization does not cover complex Cell Therapies like CAR-T cells which are considered as an ATMP and are covered by the MIA authorization mentioned above.
• “Human_Tissue_Conservation_Authorization”:  this authorization, for PDC site, covers the storage activity of human tissue which have been obtained without significant transformation meaning tissue, like Bone.
• “Starting_Materials_For_Pharma_Use_Authorization”: we have two authorizations, one for Clermont-Ferrand site and one for Pont-du-Château site. These authorizations cover the following activities: Importation, Storage, Freezing and Labeling for API and Excipients

Finally, in the context of activities related to biological samples of human origin, we have the possibility to submit applications for import/export authorization to MESRI (French Ministry of Higher Education, Research and Innovation), in the framework of a research/scientific programme, for which Cryoport Systems France is a conservation site, on behalf of foreign customers exclusively.

Before the launch of each project, Cell&Co carries out the administrative formalities relating to the operational activities and samples entrusted to it by the client, and in particular:

• Import authorization
• Export authorization
• Declaration of use of regulated biological materials.

These formalities and procedures are conducted with all competent authorities, whether in France or abroad.