Integrated quality system developed and maintained in accordance with the latest GMP EU, ISO 9001, ISO 14001 and ISO 18001 requirements.
The quality system is kept updated by continuous monitoring and analysis of external requirements, considering the guidelines developed by ISPE, ICH, PDA, FDA, PIC/S. High level of the pharmaceutical quality system is maintained by personnel trainings and qualification upgrades, team work, management reviews and CAPA system.
Governmental awards, multi-center clinical trials and absence of claims substantiate high quality of POLYSAN’s drug products.
Quality control department incudes analytical and microbiological labs with highly professional staff and state-of-the-art equipment for all the required tests. Broad experience in analytical and microbiological methods transfer.
Quality assurance department is experienced in quality control system development, implementation and maintenance by following the cutting-edge trends and in cooperation with foreign partners. Validation department ensures the entire scope of required qualification activities (equipment, engineering systems, clean rooms), process and computer-based system validation.