This demonstrates the site in China manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard
EXCiPACT asbl has announced that the Seppic Shanghai Chemical Specialities Co. Ltd site in China has recently been awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s internationally-recognised certification Bodies.
The Certificate demonstrates that the site in China, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.
Its scope covers manufacturing of veterinary vaccine adjuvants for use as pharmaceutical excipients.
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 require drug manufacturers to conduct either their own or commission 3rd 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 independent, high quality 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.