AFSSAPS and GIPC Renew GLP Certification of CIT
As part of its periodic program for inspecting testing facilities, AFSSAPS carried out a four-day inspection of CIT’s site in Evreux. AFSSAPS is the recognized authority in the field of non-clinical safety tests on medicines for human use and on cosmetics. After completing its inspection, AFSSAPS confirmed and renewed its accreditation for CIT’s GLP in the conduct of non-clinical safety trials (statute A; certification of 26 October 2010, available at http://www.citox.com).
The GIPC had already renewed CIT’s GLP status in March this year, following an inspection carried out by COFRAC (the French Accreditation Committee) in December 2009. The GIPC is responsible for chemicals, agrochemicals and other specific products.
“Ever-higher quality standards are an important and continuous objective for CIT, in order to satisfy the regulatory demands of the different authorities that inspect us regularly as well as to meet the requirements of our international clients,” said Sophie Baratte, CIT’s Managing Director.
In order to maintain that level of excellence, CIT’s management is developing its quality policy along the following lines:
- Rationalizing reference documentation to give customers a better understanding of the quality management system.
- Computerizing skills management and training.
- Developing an internal audit policy.
- Optimizing the production of study reports so as to facilitate the strict observance of deadlines.
Furthermore, in order to offer new approaches and types of study to its clients, CIT has invested heavily in new technologies and state-of-the-art equipment in 2009 and 2010. A program of qualification and validation associated with these new developments has been set up to give clients and the regulatory authorities the assurance that CIT fully mastered these new techniques.
“Examples of our new techniques include our investment in and validation of immunohistochemistry on the Ventana automaton, in particular for TCR (Tissue Cross Reactivity) studies; flow cytometry with a new 10-channel machine; the measurement of left ventricular pressure by telemetry and new in vitro techniques, e.g. phototoxicity; transcutaneous absorption; BCOP and Episkin tests,” said Dr Jean-François Le Bigot, Executive President at CIT.
In the analytical field, ICP-MS (inductively-coupled plasma mass spectrometry) now complements the LC-MS/MS and GC-MS techniques that were already available. For all these techniques, new materials have been qualified and piloting and acquisition software have been validated.
“These all represent substantial investments to ensure that CIT continues to provide excellence in serving our clients,” said Dr Le Bigot.
About CIT http://www.citox.com
CIT is a science-driven, independent, non-clinical contract research organization (CRO) specialized in safety and health research. Founded in 1969, CIT has carried out a vast number of projects for international companies on human and veterinary pharmaceuticals, biotechnology, chemicals, agrochemicals and consumer products. It has contributed to many product registrations around the world.
With a staff of 360, CIT offers a full range of research in general toxicology, reproductive toxicology, carcinogenicity, pharmacokinetics and safety pharmacology. The company also carries out research into genetic toxicology, in vitro testing and toxicogenomics.
Its 20,000 sq m (215,000 sq ft) facilities located in Normandy, one hour from Paris, France, house all principal laboratory animal species to the highest standards. Laboratory facilities include analytical chemistry and bioanalysis, clinical pathology, genomics and histology. Support facilities include archives and plant buildings. The company is GLP and AAALAC certified.
More than half the company’s business comes from international customers. Overall, 80 per cent of revenues are in the pharmaceutical and biotechnology sector. Biotechnology and start-up companies alone account for 50 per cent. The company has a world-class team of top-level management in scientific, financial and business activities.
Lynne Chapman ANDREW LLOYD & ASSOCIATES http://www.ala.com lynne@ala.com
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