Roquette has recently obtained EXCiPACT certification from SGS France, one of the international auditors authorized to grant approval under this standard.
The certificate demonstrates that the Roquette site at Lestrem, France, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) certification standard. Its scope includes 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.
EXCiPACT certification ensures top-level quality throughout the entire supply chain and gives customers access to the full documentation mandatory to the regulators.
“This certification is a new milestone in our commitment to customers” said Paul Smaltz, Roquette’s head of Pharma global business unit. “Roquette wants to offer best-in-class services to its customers, and the EXCiPACT certification was a must-have to us. The implementation of quality and safety best practices as required by EXCiPACT offers our customers the possibility to significantly reduce the number of audits. It means for them cost and time savings, while enjoying premium quality products.”
