More companies receive EXCiPACT certificates
Ensuring that cGMP and cGDP standards are being used in the manufacture of excipients
EXCiPACT, a voluntary international certification scheme designed and developed to assure cGMP and cGDP standards are being used in the manufacture and supply of pharmaceutical excipients, has announced the first Dutch and Canadian companies to receive certificates.
Sonneborn Refined Products of Amsterdam, the Netherlands has received an EXCiPACT Certificate from SGS, one of the organisation’s internationally-recognised Certification Bodies. Sonneborn Refined Products is the European arm of US-based Sonneborn LLC and a global leader in speciality hydrocarbons.
Meanwhile, A&C American Chemical Company of Saint-Laurent, Quebec, Canada has also received an EXCiPACT Certificate from SGS.
In Germany, four sites have now received certification, the latest being Biogrund of Hunstetten, Germany. This company received its certificate from DQS in Frankfurt.
The other certified sites are in France and Saudi Arabia.
EU and US pharmaceutical excipient regulations now require drug manufacturers to carry out 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 third Party EXCiPACT certification scheme is already helping excipient users and suppliers to reduce their audit burden, save costs and ensure quality.
EXCiPACT became a free-standing, not-for-profit company in January this year. It expects to register other Certifying Bodies and Auditors in the near future.
