ASHLAND’s AQUARIUS™ PLANT SITE RECEIVES EXCiPACT GMP CERTIFICATION AS PHARMACEUTICAL EXCIPIENT SUPPLIERS

Brussels, 17. May, 2016

EXCiPACT asbl is delighted to announce that Ashland’s Aquarius™ plant site has recently been awarded an EXCiPACT Certificate from SGS Belgium, one of EXCIPACT’s internationally-recognised Certification Bodies.

The Certificate demonstrates that Ashland’s Aquarius™ plant site in Wilmington, Delaware, USA manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. Its scope covers the manufacturing, testing, and packaging of pharmaceutical excipients used as film coatings in pharmaceutical industry. Relevant products are of brand Aquarius™. For full details of all sites certified to date in Canada, China, Belgium, France, Germany, The Netherlands, India, Saudi Arabia, Singapore, Spain, Switzerland, UK and USA.

Both SGS Belgium 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 now 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 new, high quality 3rd Party EXCiPACT Certification Scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and assure quality.

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