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Quality Management System

The basics of our quality policy

Quality management is fundamental for Eurogentec and is implemented by all personnel in their daily activities. In agreement with the quality policy of Kaneka Group, Kaneka Eurogentec’s top management is committed to apply the principles of quality management as described in the document below:

ISO 9001 certification

Since 2000, EUROGENTEC S.A. has maintained a Quality Management System (QMS) that is compliant and certified for ISO 9001. Our Quality Management System is ISO 9001 certified by BSI under certificate number FS 638601. The certification applies to following activities: “Development, production and sales of products and services for research and development in life sciences”.

ISO 13485 certification and compliance to 21 CFR Part 820

As of 2004 we have observed an increasing demand for high quality large-scale cGMP oligos for the In Vitro Diagnostic industry. Therefore, the following global quality vision was formulated: Eurogentec recognizes oligonucleotides as critical components of nucleic acid diagnostic medical devices. Therefore our facility and QMS should be compliant to the ISO 13485 Medical Device standard and FDA’s current Good Manufacturing Practices (cGMP) as outlined in the 21 CFR Part 820 quality system regulations. In the last years our QC, QA and production staff has been very successful in fulfilling our global quality vision for the production of cGMP oligonucleotides. Our Quality Management System is ISO 13485 certified by BSI under certificate number MD 638600. This certification is for the “Contract manufacturing of synthetic oligonucleotides in support of in vitro diagnostic and related applications”.

Compliance to European and USA Good Manufacturing Practice for Biologics

Since 1995 Eurogentec has been operating a cGMP compliant facility for the following activities

  • Cell banking
  • Microbial fermentation
  • In-line extraction, centrifugation and/or cell disruption
  • Purification (micro-filtration, crystallisation and chromatography)
  • Sterile filtration of purified bulks

The products are used for proof of principle, toxicology, characterisation, stability, Phase I / II / III human clinical trials and commercialisation. The multi-purpose manufacturing areas are operated in campaigns by qualified and experienced staff (scientists and engineers) working only in these designated cGMP areas. The quality of all operations is managed by the Quality Assurance Department, whose head is a 'Qualified Person'.

Eurogentec is authorised to manufacture biologics at its site in Liège, Belgium under the Authorisation No.: 1285, issued by The Belgian Ministry of Health.

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