expresspharmaDecember 16, 2021
Tag: GMP , Sotax Group , Ortiv-Q3
The Gujarat Food and Drug Control Administration (FDCA) commissioner Hemant G Koshia inaugurated Ortiv-Q3 pharmaceutical research and analytical laboratory in Ahmedabad. The inauguration took place in presence of the Guest of Honour Rolf Benz, CEO and President, Board of Sotax Group, the company said in a statement.
The statement further mentioned that Sotax Group and Ortiv-Q3 had recently announced their collaboration, further strengthening their capabilities in the field of pharma services.
It added that the laboratory facility is spread over ten thousand sq.ft. and is a new, state-of-the-art infrastructure including modern workspace and set of the latest instruments to perform Current Good Manufacturing Practices (CGMP) cGMP analytical services with a clear focus on complex dosage forms characterisation.
During the inauguration, Koshia said, “It will be one of the finest labs in the country, specifically in Gujarat.”
The new lab will offer various Routine Analytical Services (GMP) for QC and stability studies, clinical and commercial batch release, analytical method validation, method transfer, R&D services like in-vitro release testing (IVRT, USP type 1-7), IVPT, reverse engineering, Q3 characterisation (physico-chemical), API screening and impurities characterisation and it would also support services like troubleshooting and investigations, training, consulting, audits and support for Q1/Q2 regulatory clearance.
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