SGS is pleased to announce that it now offers full cGMP-compliant testing, concurrent with the opening of a new microbiology laboratory in their Shanghai, China facility on March 2nd, 2009. SGS Life Science Services in Shanghai provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of Traditional Chinese Medicines.
SGS Life Science Services began operations at this facility as a contract analytical laboratory for quality control testing of pharmaceuticals, biopharmaceuticals and medical devices in January 2006. The facility received ISO 17025 accreditation from the CNAL (Chinese National Accreditation Board for Laboratories) in May 2006.
The new microbiology laboratory was established under full cGMP compliance and elevates the quality standards of the service offerings in China. SGS can now provide microbiology limit test, sterility test, challenge test, and endotoxin testing services. Because the new microbiology laboratory complements the chemistry capabilities, SGS Life Science Services is able to provide one-stop services for their clients in the pharmaceutical and medical devices industries. The Shanghai Life Science Services operation covers 700 m2, employs 27 full time staff, and represents the 10th Life Science Services laboratory 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. Furthermore, “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.“
With 14 contract analytical laboratories, SGS can leverages their strong global network to deliver harmonized, GMP-compliant solutions to large pharmaceutical firms. In addition to testing services to the pharmaceutical market, SGS offers consultancy in regulatory affairs, registration of medical products in China and Hong Kong, as well as export and import related requirements. SGS provides inspection services and Second- and Third-Party GMP Auditing Services, impacting multinational companies sourcing raw materials and APIs in China.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 55,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.
SGS INSTITUT FRESENIUS GmbH
Dr. Andreas Zumdick
Im Maisel 14
T +49 6128 744 730
F +49 6128 744 207