Assessing good laboratory practices (GLP)
Good laboratory practices apply to all non-clinical safety studies concerning health and the environment as required by the regulatory authorities for type approval or authorisation purposes for medicinal products for human use, cosmetics, tattoo products, veterinary medicines and similar products, pesticides, additives for human and animal foodstuffs, and for the regulation of industrial chemical products.
Their purpose is to guarantee the reliability, integrity and quality of data generated for regulatory purposes, so that they can be used by chemical assessment authorities and be recognised internationally without the need to reproduce the studies.
Competent authorities in France
Three authorities are responsible for checking the conformity of studies with GLP principles and the test facilities in which they are carried out, according to the nature of the chemical product:
- Inspecting the application of GLP principles for tests on medicinal products for human use, cosmetic products and tattooing products is the remit of the French national agency for medicines and health products safety (ANSM - Agence nationale de sécurité du médicament et des produits de santé).
- Inspecting the application of these principles for tests on veterinary medicines and similar products is the remit of the French national agency for food, environmental and occupational health and safety (ANSES - Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail), and more specifically of the National agency for veterinary medical products (ANMV - Agence nationale du médicament vétérinaire), a branch of the ANSES.
- Cofrac controls the GLP conformity of test facilities located on French territory for tests on pesticides, additives for human and animal food, as well as on industrial chemicals. It examines the applications and monitors the files of any test facility declaring to apply the principles of GLP, organizes the inspections and ensures the recruitment of assessors and technical experts who carry them out. Cofrac takes decisions relating to GLP conformity on behalf of the State.
Regulatory texts relating to the GLP
The GLP principles are defined by directive 2004/10/EC, concerning "the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances".
These principles have been transposed into French law for tests on pesticides, additives for human and animal foodstuffs, and for industrial chemical products through Annex II to Article D523-8 of the French Environmental Code.
Terms of the GLP principles conformity monitoring program
The regulations for monitoring conformity with GLP principles are specified in Cofrac document LAB BPL REF 05, which presents and defines the various steps in the process of assessing the degree of conformity with the principles of good laboratory practices for test facilities, and specifies the rights and obligations of facilities controlled in accordance with the principles of GLP or or those applying for this control.
The fields of recognition of conformity with the GLP principles are specified in Cofrac document LAB BPL Form 05.
Test facilities controlled by Cofrac