EXCiPACT asbl is delighted to announce that Anhui Sunhere Pharmaceutical Excipients Co. Ltd in Huanan, China has recently been awarded an EXCiPACT Certificate from BV China, one of EXCIPACT’s internationally-recognised Certification Bodies.
The Certificate demonstrates that Anhui Sunhere Pharmaceutical Excipients Co. Ltd site in Huanan, Anhere, China, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the manufacture of magnesium stearate, microcrystalline cellulose and low-substituted hydroxypropyl cellulose. For full details of all sites that have been EXCiPACT certified to date in 14 Countries (Canada, China, Belgium, France, Germany, The Netherlands, India, Israel, Saudi Arabia, Singapore, Spain, Switzerland, UK and USA), see http://www.excipact.org/certification/certificates/
Both BV China and their auditors had to undergo a rigorous assessment process in order 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. BV China also had to have their auditor’s report verified by an independent certification board prior to issuing the certificate.
EU and U.S. 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.