BASF Personal Care and Nutrition’s site in Duesseldorf, Germany has been awarded an EXCiPACT GMP Certificate from SGS, one of the organisation’s internationally recognised certification bodies.
Certification demonstrates this site manufactures oleochemical products and pharmaceutical excipients according to the 2021 EXCiPACT GMP standard.
Both SGS and its auditors had to undergo a rigorous assessment process to be registered. Both have satisfied the additional competency requirements set out in the organisation’s annex to the ISO/IEC 17021-1:2015 standard. These include completion of an auditor training course, post-course 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 an independent certification board prior to issuing the certificate.
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. EXCiPACT has developed GMP and GDP standards specifically for pharmaceutical excipients, aiming to help manufacturers reduce their audit burden and costs while ensuring product quality.
