Brussels, 04 April, 2017
EXCiPACT asbl is delighted to announce that both Croda Inc. manufacturing sites in the USA have recently been
awarded an EXCiPACT Certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies.
The Certificates demonstrates that the Croda Inc. sites in Mill Hall, Pennsylvania and in New Castle, Delaware
manufacture pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP)
Certification Standard. The scope covers the manufacturing of alkyloxylates, esters and super refined oils and
PEGs at Mill Hall and the manufacturing of alkyloxylates and esters at New Castle.
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 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.