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EXCiPACT asbl has announced that Sonneborn Refined Products B.V. of Amsterdam, The Netherlands, the European arm of US based Sonneborn LLC and producer of specialty hydrocarbons, has received an EXCiPACT Certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies.
EXCiPACT Certification demonstrates that this Sonneborn site manufactures pharmaceutical excipients according to the EXCiPACT GMP and GDP certification standards.
This is the first Dutch site to receive such certification. The other certified sites are in Germany and France — see http://www.excipact.org/assets/13.12.04-Certificates-table.jpg.
Both SGS and the auditors they used had to undergo a rigorous assessment process in order to be EXCiPACT registered. Their auditors completed both the formal EXCiPACT training programme and were independently witnessed to verify that their competency was at the required standard.
EU and US pharmaceutical excipient regulations now require drug manufacturers to do either their own or third party physical audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance. The audit burden is huge. Using GMP and GDP standards designed for excipients, the new, high quality 3rd Party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.