It has been announced that Chemische Fabrik Budenheim site in Budenheim, Germany, has recently been awarded an EXCiPACT GMP/GDP certificate from SGS — one of EXCiPACT’s internationally recognised certification bodies.
The certificate demonstrates that the site manufactures pharmaceutical excipients according to EXCiPACT GMP and GDP certification standards. Its scope covers manufacturing, testing, storage and distribution of sodium, magnesium and calcium phosphates for use as pharmaceutical excipients.
EU and US pharmaceutical regulations require all drug manufacturers to wither conduct their own or commission third party physical audits of all their starting material suppliers, in order to demonstrate GMP and/or GDP compliance. Through the EXCiPACT certification scheme, which employs GMP and GDP standards designed for excipients, excipient users and suppliers may reduce their audit burden.
