EXCiPACT has announced that Croda Europe of Goole, UK, has received an EXCiPACT certificate from SGS ICS France, one of EXCiPACT’s internationally-recognised certification bodies.
The certificate demonstrates that the Croda sites at Rawcliffe Bridge and Thorne near Goole, UK, manufacture and distribute pharmaceutical excipients according to the EXCiPACT GMP and GDP certification standards.
This is the first UK site to receive certification and the 10th globally to date. The other certified sites are in Canada, France, Germany, The Netherlands and Saudi Arabia — see http://www.excipact.org/certification/certificates.
Both SGS and its auditors had to undergo a rigorous assessment process in order to be EXCiPACT registered. This required the successful completion of the formal EXCiPACT training programme and examination and an independently witnessed audit to verify that their competency was at the required standard.
EU and US pharmaceutical excipient regulations now require drug manufacturers to do either their own or third party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance. The audit burden is huge. Using GMP and GDP standards designed for excipients, the new, high quality 3rd Party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.
EXCiPACT asbl, www.excipact.org.
Croda Europe Ltd, www.croda.com.