EXCiPACT Press Release – Wacker Chemical Corporation Site
Wacker Chemical Corporation Site in Eddyville, Iowa, Usa receives EXCiPACT GMP Certification as pharmaceutical excipient supplier
EXCiPACT asbl is pleased to announce that the Wacker Chemical Corporation site in Eddyville, IOWA, 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 alpha cyclodextrin, beta cyclodextrin, and gamma cyclodextrin in kraft bags or supersacks for use as pharmaceutical according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard.
Both SGS and their auditors had to undergo a rigorous assessment process in order 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 2-day EXCiPACT Auditor Training Course, post-course 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 20 Countries (Canada, China, Belgium, Finland, France, Germany, India, Indonesia, Israel, Italy, Japan, Mexico, Romania, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA), see here.
EU and U.S. pharmaceutical regulations require drug manufacturers to conduct either their own or third-party 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.