The Illinois Corn Processing site in Pekin, Illinois, USA has recently been awarded an EXCiPACT GMP certificate from SGS, one of EXCIPACT’s, recognised certification bodies.
Both SGS and their auditors had to undergo an assessment process to be EXCiPACT registered. Both have satisfied the additional competency requirements set out in the company’s annex to the ISO/IEC 17021-1:2015 standard. These include completion of its 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.
Sites have been EXCiPACT certified to date in 21 countries (Austria, Canada, China, Belgium, Finland, France, Germany, India, Indonesia, Israel, Italy, Japan, Mexico, Romania, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA).
EU and US 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. The EXCiPACT scheme is designed to help 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.