ISO 9001 certification
Since 2000, EUROGENTEC S.A. has maintained a Quality Management System (QMS) that is compliant and certified for ISO 9001:2000. This certification was first obtained for ISO 9002 and then renewed for ISO 9001:2000 and ISO 9001:2008. The certification applies to following activities: “Development, production and sales of products and services for research and development in life sciences”.
In addition, Eurogentec North America, Inc., a wholly owned subsidiary of the EGT Group and serving the North, Central, and South American scientific community, has been in compliance with ISO 9001:2000 since September 2004. The registration was renewed in September 2007. Its scope applies to the:
“Manufacture and sales of oligonucleotides 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 13485:2003 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. In December 2008, as a result, Eurogentec (Liège production site) received ISO 13485:2003 certification for the “Production and sales of in vitro diagnostic oligonucleotides”.
At the moment, most of our cGMP oligonucleotides are still produced in our GMP facility in Belgium. We also established production facilities in North America, with complete harmonization in equipment, methods, procedures and QMS. This creates additional safety and a high quality standard for our diagnostic customers. Our North American manufacturing site in San Diego received ISO 13485:2003 certification by July 2010 for the “Manufacture and sales of oligonucleotides intended for in vitro diagnostic use”.
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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