Amsterdam, The Netherlands - December 16, 2013 – On November 19, 2013 the Certification Body SGS awarded the EXCiPACT™ Certification to Sonneborn Refined Products B.V., the European arm of US based Sonneborn LLC and global leader in specialty hydrocarbons, having met the requirements of Good Manufacturing Practices (GMP) and/or Good Distribution Practices of Pharmaceutical Excipients (EXCiPACT™) for the manufacture and distribution of Petrolatum (Petroleum Jelly), White Oils and Microcrystalline Waxes as Pharmaceutical Excipients or Chemicals claimed for pharmaceutical use. The certificate is valid until October 17, 2016.
Sonneborn Refined Products B.V. is one of the first European Excipient Manufacturers to have gained this certificate.
The safety of medicines and cosmetic products is paramount to all; the pharmaceutical and cosmetic industry, suppliers of raw materials, national and regional health care agencies, care givers and regulators. To assure the quality of medicines and cosmetic products, all risks in the supply chain need to be evaluated and minimized, including that of manufacture and distribution of excipients.
With proposed legislation requiring GMP and GDP for excipients in Europe and enforcement of existing legislation in the USA, excipient suppliers will be faced with an increasing number of (customer) audits. As a result, a group of industry experts from European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas, European Association of Chemical Distributors (FECC) and Pharmaceutical Quality Group (PQG) have worked together on the development of the EXCiPACT™ certification program for excipient suppliers. The EXCiPACT™ Certification Standards for Pharmaceutical Excipient Suppliers: GMP / GDP were issued in January 2012.
Sonneborn manufactures Petrolatums, White Oils and Microcrystalline Waxes that are used as excipients in numerous medicines and cosmetic products. On average over 80% of medicines and cosmetic products comprise excipients. “Sonneborn Refined Product B.V. worked hard to satisfy the strict requirements of these new Certification Standards, resulting in a Certification Audit by SGS in 2013 and the issue of the Certificate on November 19, 2013.” explains Dirk Pos, Sonneborn Manager QEHS. “With the EXCiPACT™ Certificate customers may rely on the quality of the excipients manufactured and distributed by Sonneborn– Amsterdam.”
For more than 100 years, Sonneborn has been setting industry standards the world over for the finest possible specialty hydrocarbons in Personal Care, Pharmaceutical, Baking & Food, Agriculture, HI&I and Microcrystalline Wax and many other applications. With manufacturing facilities in North America and Europe and offices in major cities throughout the world, Sonneborn is the world’s only specialty hydrocarbon producer that offers this global reach of expertise and depth of experience. Sonneborn LLC is owned by One Equity Partners (“OEP”), the private investment arm of JPMorgan Chase & Co.