SGS India Ltd.’s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as “acceptable.” This was the first FDA inspection of the SGS QC testing laboratory in Chennai.

“Providing high quality analytical services in all of our QC Testing laboratories is the prime commitment to our worldwide pharmaceutical clients,” said Manfred Weiler, global business manager at SGS Life Science Services. “Passing the FDA inspection is a great achievement for our Indian QC testing laboratory. It is also a result of our continuous efforts to improve and harmonize quality systems and processes throughout our network of 14 QC laboratories in North America, Europe and Asia.”

The SGS Chennai site began pharmaceutical testing in 1995, and received local GMP government approval at that time. In 1997, the facility obtained ISO 17025 certification for chemical, mechanical, and biological fields. In February 2005, the Life Science Services operations moved to Ticel Biopark, a purpose-built lab facility dedicated to R&D and drug development services. SGS occupies approximately 2400 square meters of state-of-the-art lab space for chemical, microbiological and toxicological testing. The current QC testing staff consists of more than 40 employees.

The Chennai facility provides testing services in the GMP and GLP areas: raw material and finished product testing, microbiological testing, stability testing, toxicology, biotechnology and medical device testing.