The results of "GxP-Profi 2022": what factors influence the formation of the complex of engineering solutions of the pharmaceutical enterprise

The project team of the JSC "Pharmasyntez", which took third place at the international industry competition "GxP-Profi", presented a set of engineering solutions for the production of hormonal medicines. Valery Aristov, Corporate Quality Director of the company, told the "GxP News" about what current market trends were taken into account by the team when forming this project.

What tasks of the enterprise are solved by the complex of engineering solutions presented at "GxP–Profi"?

In 2018, the JSC "Pharmasyntez", with the support of the Ministry of Industry and Trade of Russia and the Government of the Tyumen Region, began to create one of the largest in Europe and, so far, the only modern production in Russia of a wide range of hormonal medicines of various forms and dosages for hormone replacement therapy, oral contraception and treatment of gynecological diseases associated with endocrine status disorders. The key feature of this project was the fact that hormonal drugs are a highly active pharmaceutical substance that is dangerous for employees of production workshops even in low concentrations. This requires the use of special engineering solutions, complex expensive technological equipment, as well as an advanced system for ensuring and controlling the quality and safety of manufactured medicines. The complex of engineering solutions developed by the JSC "Pharmasyntez"together with key specialists of the company LLC "Pharmasintez-Tyumen" made it possible in a short time during the COVID-19 period to build and prepare for launch one of the largest high-performance plants in Europe for the production of a wide range of domestic hormonal drugs, while providing all the necessary measures for protection of the environment and personnel from dangerous effects. Within the framework of the project, modern engineering and design approaches, innovative technological equipment were used. This made it possible to ensure compliance with the very strict requirements of GMP standards of both Russia and the EAEU to the production processes and infrastructure of the enterprise intended for the production of medicines containing dangerous substances.

How did the trends of the pharmaceutical industry affect the formation of a complex of engineering solutions?
Topics relevant to the industry can be classified into two main groups: the first is the internal needs of the pharmaceutical business, and the second is the needs associated with external factors. If we talk about the own needs of the subjects of the industry, then, in my opinion, it is important for them to increase the product portfolio (primarily due to original medicines) and optimize processes. This requires innovative solutions in the field of medicine development (for example, virtual screening technologies and modeling of chemical transformations or the behavior of biological objects) and the introduction of the most advanced solutions and technologies in the design and launch of production facilities (energy-efficient solutions for ventilation or preparation of technological media, continuous granulation systems for solid dosage forms, etc.).
External impacts on business include competitive and regulatory pressure. If the effect of external factors can be leveled by increasing the volume and efficiency of activities, then innovations are needed to ensure regulatory compliance. Most often these are solutions in the field of release and operational control, as well as solutions in the field of storage and processing of GxP-relevant data. The importance and breadth of the use of information interaction tools with regulators (eCTD, AIS, etc.) is also growing.
All these factors, of course, were taken into account by us when developing and implementing a set of engineering solutions.

What role can the "GxP-Profi" competition initiated by the Eurasian Academy of Good Practices play in the development of the pharmaceutical industry?
Any innovation, if it is good, begins to be replicated, becomes generally accepted or even good practice. Nowadays, due to the changing speed of technology development, this is happening faster and faster. In some cases, innovation is a prerequisite for survival, both from the point of view of achieving business goals and from the point of view of compliance with regulatory requirements. Innovation acquires value for society after it becomes widespread and a sufficient number of suppliers of such solutions appear on the market.
The international industry competition "GxP-Profi", which presents the most interesting and effective innovative solutions, will help make pharmaceutical products more accessible and safe for consumers. This is a useful and interesting event that will ensure the optimization of key business processes in the industry, as well as reduce the use of inefficient solutions.

Reference: the company LLC "Pharmasintez-Tyumen" (Tyumen) has been part of the JSC "Pharmasyntez" since 2015. Specializes in the production of infusion solutions, medicines for the treatment of diabetes mellitus in solid dosage forms, hormonal and radiopaque medicines. The largest import-substituting project of the JSC "Pharmasyntez", implemented on the basis of the company LLC "Pharmasintez-Tyumen", for the construction of a plant producing hormonal medicines, was implemented in 2016-2022. The total volume of investments in this project is estimated at over 4 billion rubles.