Good Experimental Practice
Good Experimental Practice
GEP / GLP News
Statutory framework of GEP approval for performing officially recognised tests
Pursuant to Article R 253-1 of the Rural Code, data on the biological evaluation of plant health products (effectiveness, resistance, yield and quality of plants or plant products, phytotoxicity, side effects) are assessed using official or officially recognised tests.
According to Point II of Article R 253-14 of the Rural Code, officially recognised are tests performed by a physical or artificial person authorised to perform such tests by the Minister in charge of Agriculture, who are subject to declaration to this same Minister.
Approval is the decision whereby the Minister responsible for Agriculture authorises a body to perform officially recognised tests, intended to generate data on effectiveness and thus provide a basis for compiling biological dossiers as part of the authorisation process for putting plant health products on the market. This approval is issued by the Minister responsible for Agriculture for one or more sectors of activity and one or more sites. It is granted for a period of five years, in light of the results of an audit of the body that provides assurances on compliance with GEP requirements.
Cofrac is charged with processing applications for conformity assessments in accordance with GEP principles and the monitoring of bodies which have been granted approval, the extension of this approval to new sectors of activity and/or new experimentation units or its renewal. To do this, Cofrac organises evaluation visits and garantee the qualification and follow-up of technical experts and the audit team managers who carry them out.
Requirements to be satisfied for GEP approval
The general requirements to be respected by approved bodies or candidates for approval are laid down in the « Référentiel des exigences des bonnes pratiques d’expérimentation (BPE) relatives à l’agrément pour la réalisation d’essais officiellement reconnus », available on http://agriculture.gouv.fr/référentiel-BPE (in French).
Terms of evaluation within the framework of GEP approval
The purpose of the regulation on conformity assessment in accordance with GEP principles (Cofrac document LAB BPE REF 05 - in French) is to present and define the various stages in the conformity assessment process in accordance with the principles of Good Experimental Practice (GEP) within the framework of approval and to stipulate the rights and obligations of approved bodies or candidates for approval.
This regulation concerns approved bodies or those requesting approval with an experimentation network for performing tests in the context of biological experimentation activities, which have first submitted a statement to the Minister responsible for Agriculture to be officially recognised.
Good Laboratory Practice
The principles of GLP
The principles of good laboratory practice are applied to all non-clinical safety studies related to health and the environment required by the statutory authorities for the purposes of homologation or authorisation of pharmaceutical products, pesticides, additives for human and animal foodstuffs, cosmetics, veterinary medication and similar products, and for the purposes of regulating industrial chemical products.
Their aim is to guarantee the quality, reproducibility and integrity of the data generated for statutory purposes in order that they can be recognised internationally without it being necessary to reproduce the studies.
The competent authorities in France
Three statutory authorities are in charge of checking the conformity of GLP studies and installations where they are performed, depending on the nature of the chemical product evaluated:
- Control of the application of GLP principles is the responsibility of the French Health Products Safety Agency (AFSSAPS) regarding tests on pharmaceutical products and cosmetics products.
- Control of the application of these principles is the responsibility of the French Food Safety Agency (AFSSA) regarding tests on veterinary medication and similar products.
- The Groupe Interministériel des Produits Chimiques (GIPC) is in charge of controlling the application of GLP principles for tests on pesticides, additives for human and animal foodstuffs, and on industrial chemical products. This authority has entrusted COFRAC with processing applications and monitoring dossiers on all test installations claiming to apply GLP principles. COFRAC organises inspections and handles the recruitment of the inspectors and technical experts who carry them out.
The statutory texts on the GIPC
GLP principles are defined by Directive 2004/10/EC, on "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 the tests on pesticides, additives for human and animal foodstuffs, and industrial chemical products by Article Annex II to Article D523-8 of the Environmental Code of 16 October 2007.
Terms of the GIPC's GLP inspection programme
The regulation on conformity assessment in accordance with GLP principles is stipulated in the Cofrac document, LAB BPL REF 05 (in French), the purpose of which is to present and define the various stages in the process of assessing the degree of conformity to the principles of good laboratory practice of test installations and to lay down the rights and obligations of installations recognised as being in compliance with these principles or candidates for such recognition.
The fields of conformity recognition in accordance with GLP principles are stipulated in the Cofrac document, LAB BPL Form 05 (in French - on page 6).