Wacker Receives Excipient Certification

EXCiPACT asbl has awarded Wacker Chemical Corporation’s site in Eddyville, IA, with an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally recognized 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 US.

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