Three regulatory authorities are responsible for verifying the conformity of the GLP studies and the facilities where they are carried out, depending on the nature of the chemical being evaluated.
- medicinal products for human use, cosmetics and tattoo products, medical devices: ANSM;
- veterinary medicinal products: Anses-ANMV;
- other chemicals: COFRAC.
Registration in the Anses-ANMV GLP inspection program is a prerequisite for any inspection request. This is a voluntary approach of the structure concerned.
The entry concerns any testing facility located in France and declaring to apply GLP for the conduct of non-clinical and pre-clinical safety tests for veterinary medicinal products.
The list of documents to be provided for the preparation of a GLP file is available below.
In addition, to complete the registration in the GLP inspection programme, a supplement is sent by post or e-mail to the inspection unit (see contact) specifying:
- name and full address of the test facility;
- name, function, telephone, contact mail in test facility to be inspected;
- OECD area(s) concerned by the studies carried out;
- date of completion of the first study and desired inspection date.
If the activities of the test facility are effectively within the competence of Anses-ANMV and if at least one study is completed, an inspection will be notified to the Director of the Test Facility by the Director of Anses-ANMV, by letter stating:
- the persons who will participate in the inspection (lead inspector, associate, prospective expert), the date, duration and scope of the inspection;
- the obligation to submit at least 15 days before the inspection an updated test facility status, in accordance with Decision 2010/03/131 of 24 March 2010 on the state of play of the test facilities and Annex “GLP — Situation review”; or, for mixed test facilities (also carrying out studies for the medicinal product for human use), in accordance with the state of play required for testing facilities by the ANSM (current version).
On-site inspections are intended to determine the degree of compliance of testing facilities with the principles of good laboratory practice for the veterinary medicinal product.
Depending on the nature and extent of the non-compliance with the GLP identified and/or persisting as a result of the proposed corrective measures, the test facility is assigned a compliance status according to the classification of the Order of 28/01/2005:
- A: in compliance with GLP, if no deviation or only a minor deviation is retained;
- B: in partial compliance with GLP, if the minor deviations identified do not affect the reliability of the studies carried out, and EI has committed to correct these deviations;
- C: not GLP compliant, if serious deviations are not addressed by corrective measures deemed adequate.
To access the “Inspection” page
To access the regulatory referential
List of documents to be provided for a GLP dossier (+ OECD nomenclature) (PDF in French)