SGS has opened a new microbiology lab offering full cGMP-compliant testing in its Shanghai, China facility. The facility provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of traditional Chinese medicines.

The new microbiology lab was established under full cGMP compliance, enhancing quality standards of service offerings in China. The company can now provide microbiology limit test, sterility test, challenge test, and endotoxin testing services. The Shanghai operation covers 700 m2, employs 27 full time staff, and is the 10th life science services lab to operate under GMP.

“This development is significant because throughout 2008, SGS received increasing requests from several multinational companies for microbiology testing in a fully cGMP-compliant environment – and based on this requirement we have a solution,” said Ulrich Markens, vice president and regional business manager, Asia Pacific. “The construction of the microbiology lab is part of the strategy for our Life Science Services operations in China. Integrating microbiological testing broadens our service portfolio while implementing a dedicated cGMP-compliant Quality Management System for the entire laboratory. This ensures a quality improvement level which is demanded by our multinational customers and in compliance with the increased scrutiny of pharmaceutical manufacturing in China by US FDA.”