EU and US regulations now require drug manufacturers to conduct physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance
EXCiPACT is pleased to announce that Novacarb France has recently been awarded an EXCiPACT certificate from SGS ICS France, one of EXCiPACT’s internationally recognised certification bodies.
The certificate demonstrates that the Novacarb site at Laneuveville-devant-Nancy, France, manufactures pharmaceutical excipients according to the EXCiPAC good manufacturing practice (GMP) certification standard.
This is the fourth site in France to receive EXCiPACT certification since 2013 and is the 25th site to be certified globally to date. The others sites are in Canada, China, Belgium, Germany, the Netherlands, Saudi Arabia, Spain and the UK.
Both SGS ICS France and their auditors had to undergo a rigorous assessment process to be EXCiPACT registered. This required the successful completion of the EXCiPACT training programme and post-course examination followed by an independently witnessed audit to verify that their competency was to the required standard. SGS also had to have their auditor’s report verified by an independent certification board prior to issuing the certificate.
EU and US pharmaceutical regulations now require drug manufacturers to conduct either their own or commission third party physical 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 new, high quality third party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.