Medlar receives OECD certification for GLP
EPP News Bureau – Mumbai
Medlar Laboratories, a Mumbai-based contract research company and an affiliate of pharma major Cipla, has been awarded Good Laboratory Practice (GLP) certification by the Organisation for Economic Cooperation and Development (OECD). Medlar is only the second laboratory in India to be certified by OECD. The inspection was carried out by SNAS inspectors Dr Emil Tomasik and Dr Miloslav Foltin and was found confirming to the principles of GLP in accordance with OECD international guidelines, a Medlar release says. OECD approval is an essential accreditation for laboratories if the data generated is to be considered for the purpose of product registration in European countries.
Medlar operates on a total area of 15,000 sq.ft housing bioclinical centre, bioanalytical laboratory, quality control laboratory and administrative office. It is well equipped with many sophisticated analytical instruments such as GC-MS, LC-MS, XRD, DSC and TGA. The bioanalytical laboratory is equipped with latest models of GCs and HPLCs with freezer auto injectors and UV-VIS, fluorescence, electrochemical and refractive index detectors.
The services offered include bioequivalence evaluations of generic products, dose-proportionality bioavailability studies, therapeutic drug monitoring, evaluations of new drug delivery systems, phase 1 to 2 pharmacokinetic studies for NCEs, food effect studies, and evaluation of controlled and extended release dosage forms.