Today ACADEMPHARM is a dynamically developing high-tech state-owned pharmaceutical enterprise of production and distribution of drug substances and biologically active additives of high quality. In spite of the young age for the pharmaceutical industry, ACADEMPHARM has already filled a niche on the domestic market and continues to expand it. In 2011 ACADEMPHARM produced 6 kinds of drug products, and in 2021 – already 40.
Manufacturing
The production lines are equipped with the latest equipment from leading world companies that meets all GMP requirements.
In 2012
three presentation forms of drug products were implemented:
Tablets
Capsules
Sachets
In 2014
New equipment was placed into operation – a blister packaging machine for packing tablets and capsules in blister pack and a machine for automatic packaging in cartons by HOONGA in the newly built ABK building (administration and amenity building).
The total storage area of the state-owned enterprise ACADEMPHARM is more than 1250 sq.m.
Quality system
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.
Department of Research and Development
Laboratory of technology of finished dosage forms carries out the development of formulations and production technology of oral drug products. For these reasons the laboratory is equipped with the necessary technological and analytical equipment.
Technological equipment is designed to develop various technological processes that simulate the conditions of industrial production:
- preparation of tablet / capsule mass,
- tableting / capsule filling
- tabletscoating
In the Laboratorytest methods of drug substances and finished dosage forms are developed, as well as stabilitystudies of finished dosage forms during storage under natural and accelerated conditions are carried out.
To confirm the equivalence of the developed drug product to the original drug an in vitro dissolution test is used. During the test three basic dissolution media with different pH values are used: 1.2-corresponds to an empty human stomach, 4.5-corresponds to a full stomach, 6.8-corresponds to an intestinal medium. Thus, only after confirmation of the equivalence in vitro, it is possible to obtain permission to conduct bioequivalent or clinical trials on humans.
The enterprise is recognized to be competent in performance of research and development, experimental and technological works, and is accredited as the scientific organization (the Certificate of accreditation of the Scientific organization No. 205 of March 16, 2018).
