SGS New North America Facility Receives GMP Certification from the EMA
SGS Life Science Services announced today that its new North American facility passed an audit conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the European Medicinal Agency (EMA). SGS Life Science Services – R&D/QC division performs methods development and quality control testing for the pharmaceutical, biopharmaceutical, medical device, chemicals and cosmetics markets.
SGS operates three US-FDA registered sites in North America performing these GMP services: New Jersey, Illinois and Mississauga, Canada. In May 2010, SGS completed the move of its suburban Chicago site from Northbrook to Lincolnshire, Illinois. The move effectively doubled the facility size from 21,500 square feet to almost 40,000 square feet. On June 18, 2010, GMP inspectors from the UK MHRA performed a product-related inspection of the Lincolnshire site. SGS subsequently received GMP certification for chemical and physical testing in August.
“For SGS, receiving the EMA GMP certification at the new Lincolnshire facility means that the North American team has honored SGS’s commitment to delivering the highest quality and service,” said Don Castle, Sr. Vice President and Regional Business Manager, North America. “As part of the move, SGS increases its offerings in Stability Studies and Stability Program Management. We are delighted with expanding our service offerings to better serve the needs of our pharmaceutical customers.”
With 13 laboratories offering contract analytical services, SGS leverages its strong global network to deliver harmonized, solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the pharmaceutical market, SGS also offers provides clinical trial management (Phase I to IV) and services encompassing bioequivalence studies, bio-analytical services, data management, biometrics and regulatory consultancy.
Global Marketing Director
Life Science Services – R&D/QC
75 Passaic Avenue,
Fairfield, NJ 07004, USA
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 59,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.