Quality
From Research to GMP Quality
The quality of the products we deliver is fundamental for us. We know that it influences significantly assay performance. Accordingly, Eurogentec has maintained a Quality Management System that guarantees each employee always operates with respect to standard procedures and fulfills our global quality policy.
ISO 9001 certification
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
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”.
Regulations for in vitro diagnostics (IVD)
Eurogentec manufactures products in support of in vitro diagnostic and related applications. The IVD medical device industry is regulated by FDA GMP/QSR (21 CFR Part 820), EU IVD Directive 98/79 EEC and EU 2017/746 Regulation. These regulations are not applicable to Eurogentec as it does not manufacture medical devices.
However Eurogentec quality system is compliant to the applicable quality system requirements of these regulations.
Compliance to European and USA Good Manufacturing Practices for Biologics
Eurogentec manufactures biopharmaceuticals according to the European Commission’s Directive 2003/94/EC, EudraLex Volume 4 regulations as well as the US FDA’s 21 CFR Part 210 and 211 GMP manufacturing requirements for biopharmaceuticals.
Eurogentec is accredited by the Belgian Federal Agency for Medicines and Health Products for the manufacture of clinical trial and commercial material in its facilities in Liege, Belgium (Authorisation No.: 1285)
Our GMP facilities are compliant for the following activities:
- Cell banking
- Microbial fermentation
- In-line extraction, centrifugation and/or cell disruption
- Purification (tangential flow filtration, crystallization and chromatography)
- Sterile filtration of purified bulks
The products are used for proof of principle, toxicology, characterization, stability, Phase I / II / III human clinical trials and commercialization. The multi-purpose manufacturing areas are operated in campaigns by qualified and experienced staff (scientists and engineers) working only in these designated GMP areas.
The quality of these operations is managed by the Quality Assurance Department, whose head is a 'Qualified Person'.