EXCiPACT’s scheme uses GMP and GDP standards designed specifically for pharmaceutical excipients
The Innophos site in Chicago Heights, Illinois, USA has recently been awarded an EXCiPACT GMP Certificate from SGS, one of EXCIPACT’s internationally recognised Certification Bodies.
The certificate demonstrates the site manufactures calcium phosphates as pharmaceutical excipients according to the 2017 EXCiPACT GMP certification standard.
Both SGS and its auditors had to undergo an assessment process to be EXCiPACT registered. Both have satisfied the additional competency requirements set out in the EXCiPACT annex to the ISO/IEC 17021-1:2015 standard.
These include completion of the auditor training course, postcourse written examination and independently witnessed audit to verify their competency to the required standard. SGS also had to have its auditor’s report verified by their independent certification board prior to issuing the certificate.
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. Using GMP and GDP standards designed specifically for pharmaceutical excipients, EXCiPACT says its certification scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, to reduce their audit burden.