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ASHLAND INDUSTRIES NEDERLAND’S ZWIJNDRECHT SITE RECEIVES
- Publisher:
- Publication:2016/10/26
NEWS RELEASE
ASHLAND INDUSTRIES NEDERLAND’S ZWIJNDRECHT SITE RECEIVES
EXCiPACT GMP CERTIFICATION AS PHARMACEUTICAL EXCIPIENT
SUPPLIERS
Brussels, 25 October 2016
EXCiPACT asbl is delighted to announce that Ashland Industries Nederland’s Zwijndrecht site
has recently been awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s
internationally-recognised Certification Bodies.
The Certificate demonstrates that Ashland Industries Nederland’s Zwijndrecht site in The
Netherlands, manufactures pharmaceutical excipients according to the EXCiPACT Good
Manufacturing Practice (GMP) Certification Standard. Its scope covers the manufacturing of
Hydroxy Ethyl Cellulose (Natrosol Pharm type) as a pharmaceutical excipient. For full details
of all 43 sites 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 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.
Notes for the Editor
EXCiPACT asbl provides management oversight for a high quality, voluntary international EXCiPACT Certification Scheme that provides
for independent 3rd party GMP and/or GDP certification of manufacturers, suppliers and distributors of pharmaceutical excipients
worldwide. The Scheme will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient
supply chain. It has been operational since early 2013 since when there has been considerable interest among pharmaceutical excipient
suppliers, customers and regulators. For further information see www.excipact.org or contact info@excipact.org.
EXCiPACT is a registered trademark.
ASHLAND INDUSTRIES NEDERLAND’S ZWIJNDRECHT SITE RECEIVES
EXCiPACT GMP CERTIFICATION AS PHARMACEUTICAL EXCIPIENT
SUPPLIERS
Brussels, 25 October 2016
EXCiPACT asbl is delighted to announce that Ashland Industries Nederland’s Zwijndrecht site
has recently been awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s
internationally-recognised Certification Bodies.
The Certificate demonstrates that Ashland Industries Nederland’s Zwijndrecht site in The
Netherlands, manufactures pharmaceutical excipients according to the EXCiPACT Good
Manufacturing Practice (GMP) Certification Standard. Its scope covers the manufacturing of
Hydroxy Ethyl Cellulose (Natrosol Pharm type) as a pharmaceutical excipient. For full details
of all 43 sites 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 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.
Notes for the Editor
EXCiPACT asbl provides management oversight for a high quality, voluntary international EXCiPACT Certification Scheme that provides
for independent 3rd party GMP and/or GDP certification of manufacturers, suppliers and distributors of pharmaceutical excipients
worldwide. The Scheme will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient
supply chain. It has been operational since early 2013 since when there has been considerable interest among pharmaceutical excipient
suppliers, customers and regulators. For further information see www.excipact.org or contact info@excipact.org.
EXCiPACT is a registered trademark.