Universitat Jaume I - UJI - Castello

Certification

On 16 November, 2001, LARP first gained a GLP Certificate following accreditation by Entidad Nacional de Acreditación (ENAC). The Certificate, which was most recently renewed in April 2008 following an audit by ENAC (08/17/BPL22), is for residue studies of plant protection products in vegetables and water.

As previously mentioned, the present GLP activities of LARP are focused on the development and validation of analytical methodology and the application of this methodology to the determination of residues in different matrices.

LARP has recently moved to a new building, which allows an increase in capacity and improves operations, including the performance of GLP compliant formulation studies.

One of the main purposes of studies on environmental and toxicological samples is to obtain data on their safety regarding to human health and environment. Studies are required under regulations for the purpose of registering or licensing pharmaceuticals, pesticides, cosmetic products, veterinary drugs and similar products as well as food additives, feed additives, and for the regulation of industrial chemicals. Good Laboratory Practices (GLP) is a quality system covering the organisational processes of a laboratory and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. While it is a requirement of EU Directive 91/414/EEC to perform testing with this accreditation it also gives clients assurance that the testing is done in an appropriately controlled way.

The key purpose of the application of the Good Laboratory Practices quality programme is the assurance of quality test data. This constitutes the basis for mutual acceptance of data amongst countries. In this sense, GLP is a set of uniform rules and operating procedures, mandatory to assure the quality and integrity of the data produced in specified investigations or studies. The guide-lines of GLP have been developed by the Organisation for Economic Co-operation and Development (OECD) and are set out in the EU Directives 87/18, 99/11 and 2004/10/EC and included in Spanish legalisation, RD 822/1993 and RD 1369/2000.

For pesticides registration, Council Directive 91/414/EEC establishes that only plant protection products that have the active substance included in Annex I can be commercialised. There is a complex procedure for the inclusion of an active substance in Annex I. To ensure the products have no harmful affects on human health, the manufacturer must provide information on physico-chemical properties, methods of analysis, toxicological and transformation studies, residue levels in treated products, and distribution in the environment. For the registration of formulates and to establish Maximum Residue Limits (MRL) in Member States, it is a requirement to undertake GLP studies, mainly as residue trials.

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Information provided by: Institut Universitari de Plaguicides i Aigües