SGS Awarded cGMP Accreditation for New Italian Analytical Laboratory
News Nov 07, 2014
SGS Life Science Services has announced that it has been awarded cGMP accreditation for its newly added analytical laboratory, at its Livorno, Italy facility.
SGS’s first dedicated life science laboratory in Italy, the new lab will focus on analytical quality control testing, IT compliance and validation, and complements the existing service offer at the Livorno site, which provides facilities qualification, calibration and validation services, and an analytical chemistry laboratory which opened in 2013.
The 1,085m2 laboratory employs 25 staff, is also ISO 9001 accredited, and completes the SGS Life Science Services offering for the Italian market. cGMP accreditation enables the Livorno GMP laboratory to demonstrate, on behalf of it clients, whether or not individual batches of their raw materials, or of their regulated product, are manufactured according to the highest quality standards.
“The investment in the new laboratory and its cGMP accreditation adds significantly to our existing offer and will enable us to conveniently serve the microbiological and chemical testing needs of our clients in the important Italian market, where many multinational pharmaceutical firms and API manufacturers are located,” commented Marco Benvenuti, Business Manager, SGS Life Science Services.
Frédéric Gaussens, Vice President Global Strategy and Business Development, SGS added, “The Livorno facility further strengthens our global footprint in Europe and provides great synergies with our current method development, equipment and instrument validation and calibration services. This investment is key to our ongoing expansion program, both strategically and geographically.”
With 21 laboratories offering GMP/GLP-compliant contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms.
From supporting drug development to performing quality control testing of raw materials and finished products, SGS’s laboratory services include analytical chemistry, microbiology, stability studies, biosafety, and protein analysis. SGS also provides Phase I to IV clinical trial management and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.