QUALITY MANAGEMENT

Based on national law and international cGMP regulations - including the Code of Federal Regulations (21 CFR 210-211) of the US FDA and the EC Guide Part II (ICH Q7A) - a quality assurance system has been established to regulate all quality sensitive methods and procedures as well as to ensure cooperation and support from employees at all levels.

The Quality Control department consists of Quality Control, Quality Assurance and Regulatory units. The duties and responsibilities of the Quality Control department, Quality Assurance department and responsibilities for production units are separate from one another.

Quality management requires a system for continuous quality improvement, preventive quality assurance and integration of potential cost savings to ensure the continued high quality of all our activities and products. Deviations from these methods are investigated and evaluated.

The Management distinguishes between preventive and corrective actions, both of which are used in the quality control system in a transparent and open manner by all involved parties. Regular audits and inspections are performed in order to confirm compliance with all applicable customer and regulatory guidelines.