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 pharmaceutical products, pesticides, additives for human and animal foodstuffs, cosmetics, veterinary medicines and similar products, and for the regulation of industrial chemical products.
Their purpose is to guarantee the quality, reproducibility and integrity of the data generated for regulatory purposes so that the data can be recognised internationally without the need to reproduce the studies.
Competent authorities in France
Three regulatory authorities are responsible for checking the conformity of the GLP studies and the facilities in which they are carried out, according to the nature of the chemical product assessed :
- Inspecting the application of GLP principles for tests on pharmaceutical products, 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.
- The GIPC (Groupe interministériel des produits chimiques - Interministerial Chemical Products Group) is responsible for inspecting the application of GLP principles for tests on pesticides, additives for human and animal foodstuffs, and industrial chemical products. This authority entrusts Cofrac with the review and monitoring of applications for any test facility declaring that it applies GLP principles. Cofrac organises inspections and handles the recruitment of the inspectors and technical experts carrying them out.
Regulatory texts relating to the GIPC
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 inspection programme from the GIPC
The regulations for assessing 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 recognised to be in conformity with these principles or those applying for this recognition.
The fields of recognition of conformity with the GLP principles are specified in Cofrac document LAB BPL Form 05 (on page 7).