This is the fifth site in France to gain certification since 2013
Roquette Freres' plant in Lestrem, France, has earned EXCiPACT certification for Good Manufacturing Practice (GMP) from SGS France, one of EXCIPACT’s internationally-recognised certification bodies.
The certificate covers the design, production and storage of excipients made from amylaceous substances such as certain starches and glucoses; sorbitol, maltitol, mannitol and xylitol powders; and maltitol solutions.
This is the fifth site in France to receive EXCiPACT Certification since 2013 and is the 29th site to be certified globally to date. The other sites are in Canada, China, Belgium, Germany, India, The Netherlands, Saudi Arabia, Spain, US and the UK.
EU and US pharmaceutical regulations now require drug manufacturers to conduct either their own or commission third party audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden. Using GMP and GDP standards designed for excipients, the EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce this burden, save costs and ensure quality.