DuPont Site In Newark, Delaware, USA Receives EXCiPACT GMP Certification As Pharmaceutical Excipient Supplier
Brussels, 04 February 2022
EXCiPACT is pleased to announce that the DuPont Nutrition USA, Inc. site in Newark, Delaware, USA has recently been awarded an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally recognised Certification Bodies.
The Certificate demonstrates that this site manufactures colloids, binders, sodium croscarmellose and coatings to be used as pharmaceutical excipients according to the 2021 EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.
Both SGS and their auditors had to undergo a rigorous assessment process to be EXCiPACT Registered. Both have satisfied the additional EXCiPACT competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021 1:2015 standard. These include completion of the EXCiPACT Auditor Training Course, postcourse written examination and independently witnessed audit to verify their competency to the required standard. SGS also had to have their auditor’s report verified by their independent certification board prior to issuing the certificate.
For full details of all sites that have been EXCiPACT certified to date in 22 Countries (Austria, Belgium, Canada, China, Czech Republic, Finland, France, Germany, India, Indonesia, Israel, Italy, Japan, Mexico, Romania, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA).
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or thirdparty physical risk assessment audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden. However, using GMP and GDP standards designed specifically for pharmaceutical excipients, the voluntary, independent, high quality, EXCiPACT Certification Scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, to reduce their audit burden, to save costs and to assure product quality
Download the ExciPact press release: Excipact Press Release – DuPont Nutrition USA