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Quality Management
In line with the national and international guidelines, we are continuously improving our quality system, thereby ensuring that production and testing are conducted at high quality and safety standards and in compliance with current requirements of GMP and GLP regulations.
GMP
High quality standards are guaranteed by:
- GMP-compliant documentation (QM manual, PIC SMF, validation master plan, training documents, annual product review, SOPs)
- High quality of source material and end product (quality audits of suppliers and testing labs)
- High standards for personnel training (planning, execution and documentation of training programs)
- Continuous improvement of process quality (self inspection, quality assurance circle, analysis of OOS results and deviations, corrective and preventive action (CAPA))
GLP
Since 2003 EUFETS AG has been certified according to the Chemikaliengesetz and Directive 88/320/EEC as a GLP test facility and provides GLP compliant in vitro safety and efficiency testing on biopharmaceuticals. GLP compliance is guaranteed by an ongoing quality assurance program throughout the whole testing process including study plan, study and raw data inspection and final report.
EUFETS provides regulatory affairs support und services for your clinical trials, including advice and consultancy and dossier preparation. EUFETS can assist you in the following areas:
- Discussion with regulatory authorities on your behalf
- Preparation of scientific reports
- Manufacturing authorization application
