Cognis receives GMP Compliance for Pharmaceutical Excipients
19 July 2006
Cognis Germany recently became the first chemical company in the world to obtain GMP compliance for its pharmaceutical excipients. After successfully completing an audit carried out by the German Association for Certification of Quality Management Systems (DQS), the company's Düsseldorf site was certified GMP-compliant with no reservations. The certificate covers nutrition and health's PharmaLineTM product range.
Cognis' processes are based on the Good Manufacturing Practice (GMP) principles, and as such, they fulfil the standards of the International Pharmaceutical Excipients Council (IPEC). These include transparency in manufacturing processes, adherence to strict guidelines in the area of hygiene, and comprehensive documentation of production processes. The GMP Pharma standard sets even stricter benchmarks in the areas of training and hygiene, pest control, cleaning of production equipment, documentation of individual process steps, traceability of intermediate products and raw materials, and supplier auditing.
Certification leads to commercial opportunities. The audit procedure required the DQS to carry out a thorough inspection of Cognis' production facilities and laboratories. The outcome of these was extremely positive. Cognis has successfully incorporated the GMP criteria into its own quality management system, for which it already has ISO 9001 and ISO 14001 certifications. The audit report also praised the excellent standard of Cognis' production facilities.
Jochen Seifert, Global Product Line Manager for pharmaceuticals and healthcare comments,"GMP certification marks an important step forward in our efforts to market PharmaLine™ products internationally. It opens up new markets for us, and it also saves our customers from having to carry out their own separate audits."
About Cognis
Cognis is a worldwide supplier of innovative specialty chemicals and nutritional ingredients, with a particular focus on the areas of wellness and sustainability. The company employs about 8,000 people, and it operates production sites and service centers in 30 countries.
Cognis has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for the food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Another main focus is on products for a number of other industries, such as coatings and inks, lubricants, textiles, as well as agriculture and mining. The company holds a 50% stake in the joint venture Cognis Oleochemicals, one of the world's leading manufacturers of oleochemicals.
Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and SV Life Sciences. In 2005, Cognis recorded sales of €3.18 billion and Adjusted Earnings Before Interest, Income Taxes, Depreciation, Amortization and Exceptional Items (EBITDA) of €356 million.
