Good practices and GLP

 

IMMR has all the authorizations and is fully accredited from the relevant French regulatory institutions in order to practice animal research.

Our institutional ethics committee makes sure studies performed at our facility are conducted in compliance with the Guide for the Care and Use of Laboratory Animals and in accordance with European Community recommandation.

All studies are performed according to basic “good practices”, however, studies can be performed according to Good Laboratory Practice (21 CFR part 58), including the use of written protocols, standard operating procedures, skilled and trained associates, calibrated equipment, accredited animal facilities, proper data tracking, biostatistics, final reports, etc.

Quality assurance has become of paramount importance in our daily life at IMMR. Surgery is a craft, and we are indeed experts in this field. But our customers are buying a lot more than our technical know-how in the operating room: they are buying data. Generating data requires constant scrutiny, verification, validation, interpretation, and archiving. A robust quality assurance system is therefore necessary. We follow the methods of Good Laboratory Practice to assure the highest professional standards in the field of large animal surgery and medical devices.

Audit FDA IMMR 2013