The state-owned enterprise ACADEMPHARM has national GMP certificates for the production of all forms of presentation of its own products.
A pharmaceutical quality system developed in accordance with the requirements of national standards of Technical code of common practice (TKП) 030-2017 (33050) “Good Manufacturing Practice” and international requirements has been introduced and operates in the company.
The pharmaceutical quality system includes good manufacturing practice, quality control and quality risk management. The system is fully documented and its effectiveness is controled. All units of the quality system are provided with a highly-qualified personnel, a sufficient number of appropriate facilities, equipment and technical facilities.
As part of the quality system, the company has a Quality Assurance Department and a Quality Control Department, including:
• physico-chemical laboratory
• microbiological laboratory
• group of inspectors.
The Quality Control Department of the enterprise is certified for compliance with STB ISO / IEC 17025.
A multi-stage quality control system provides incoming control of raw and other materials, manufacturing process control and quality control of released drug products.
State-of-the-art laboratory equipment, the methods used, validation of quality control techniques and production processes, as well as high professionalism of specialists guarantee the quality of the products.
Further product control is carried out during the entire shelf life of retain sample of any batch. Pharmacovigilance, Drug Safety Monitoring System, is operating in the company.
The state-owned enterprise ACADEMPHARM guarantees compliance of products with its intended use and the requirements of registration documents, minimizing the risk to patients associated with the safety, quality and effectiveness of manufactured drug products.