Specialty chemical supplier Cognis receives GMP compliance for pharmaceutical excipients
First chemical company to obtain GMP compliance
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 & Health's PharmaLineTM product range.
Cognis' processes are based on the Good Manufacturing Practice (GMP) principles, and as such, they fulfill 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, and 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 certification. The audit report also praised the excellent standard of Cognis' production facilities. Comments Jochen Seifert, Global Product Line Manager, Pharmaceuticals & Healthcare: "GMP certification marks an important step forward in our efforts to market PharmaLineTM products internationally. It opens up new markets for us, and it also saves our customers from having to carry out some of their audits."
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