EXCiPACT asbl is delighted to announce that the Ashland Speciality Ingredients site in Doel, Belgium has
recently been awarded an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally-recognised
Certification Bodies.
The Certificate demonstrates that the Ashland Speciality Ingredients (ASI) site in Doel, Belgium, manufactures
pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification
Standard. Its scope covers the production of methylcellulose (MC), hydroxypropylmethylcellulose (HPMC) and
methylhydroxyethylcellulose (MHEC) as pharmaceutical excipients. For full details of all sites that have been
EXCiPACT certified to date in 15 Countries (Canada, China, Belgium, France, Germany, India, Israel, Japan, Saudi
Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA), see
http://www.excipact.org/certification/certificates/
Both SGS 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.
SGS 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.