GOOD LABORATORY PRACTICE (GLP)
Good Laboratory Practice (GLP) regards “the organizational structure and the conditions for the programmation, execution, control, registration of non - clinical studies about the security on human health and the environment”. GLP principles are applied to all the non clinical studies and to studies for environmental safety (with the exception of possible exemptions ruled by National legislation) required by the regulations for the registration and commercialization of medicinal products, pesticides, additives for food and feed, cosmetics, medicinal products for veterinary use and similar products, and to the registration of industrial chemical substances.
Chelab is certified by the Italian Ministry of Health as assay centre operating in conformity with GLP principles regulated by the Legislative Decree n. 50/2007. GLP test facility is included in the national monitoring programme of GLP and is regularly inspected by the competent authority ( every 2 years) that certifies the conformity to GLP principles (certification nr. 86/2009).
The types of studies that our assay centre perform in conformity with GLP include physical - chemical tests, toxicity studies, mutagenesis studies, studies of enviromental toxicity on aquatic and land organisms, studies on behaviour in water, soil, air; bio-accumulation, residues studies, studies of clinical and analytical chemistry, metabolism and pharmacokinesis (only for the bioanalytical part) and other studies.
The studies performed in GLP by Chelab are recognized by all the countries complying with OCSE decisions about the mutual recognizement of data for the evaluation of substances and of finished chemical products (C(81)30Final and C(97)114Final)
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