TASS press conference on 2022 GxP-Profi
TASS press conference on 2022 GxP-Profi
The 2022 edition of GxP-Profi was held from 1 July to 10 November by the Eurasian Academy of Good Practices in cooperation with the Ministry of Industry and Trade of the Russian Federation, and with the support of the Eurasian Economic Commission. The goal of the international professional excellence awards is to identify the leading EAEU pharmaceutical manufacturers in terms of quality assurance.
Given the radical transformation that the world is experiencing now, the pharmaceutical industry’s innovation-driven development has come to the fore. Ensuring Russia’s technological independence is one global task that the country’s economy is facing. In order to do that, it is particularly important to take into consideration the experience of the industry leaders. And this is why the 2022 GxP-Profi awards became a platform for identifying and scaling up innovation across the EAEU.
Dmitry Galkin, Director of the Department for Development of the Pharmaceutical and Medical Industry, Ministry of Industry and Trade, expanded on the pharma industry’s current challenges in securing the country’s sustainable drug supply. ‘First, the COVID-19 pandemic showed us what it means to have your own production, raw materials and suppliers you can rely on. Then came new challenges related to logistics, financial arrangements and the withdrawal of a number of long-standing contractors. On the one hand, these factors led to additional economic costs and longer hours. On the other hand, they helped broaden our horizons and made us look elsewhere for new international partners – whose number is significant – but also turn our attention toward internal cooperation. Now we are all readjusting ourselves to become even stronger’, explained Dmitry Galkin.
The main goal for the immediate future is to develop our own production of medicines and raw materials, including fine chemicals. According to Dmitry Galkin, over RUB 5bn more will be allocated for the development of select productions and subsidizing of specific synthesis solutions in 2 years. He also highlighted the importance of 2022 GxP-Profi in stimulating innovation.
‘In the recent years, the actively growing pharmaceutical industry has been one of the top priorities, attracting significant investments. The development of innovative medicines and hi-tech production has been gradually taking center stage. However, the pharmaceutical industry is subject to many regulations, because safety is key at all stages, from development to manufacturing. Not a single pharmaceutical enterprise today can operate without adhering to rules and GMP. Success can be achieved through constant improvement, which means focusing on upgrading and advancement. The lives and wellbeing of our population depend on the quality and effectiveness of our medicines’, pointed out Vladislav Shestakov, member of the expert committee, Head of the State Institute of Drugs and Good Practices, Ministry of Industry and Trade.
Vladislav Shestakov believes that for pharmaceutical companies GxP-Profi represents a chance to showcase their achievements and promote their advancements in improving product quality. ‘This award was designed to help the EAEU pharma manufacturers reveal their potential in innovations and quality, and demonstrate innovative solutions, thus enhancing the image of the EAEU pharma companies, and boosting their competitive advantage in both domestic and international markets’, highlighted Vladislav Shestakov and went on to express his gratitude to the Ministry of Industry and Trade for their support.
This resonates with Chinara Mambetaliyeva, member of the expert committee, Deputy Director of the Department of Technical Regulation and Accreditation, Eurasian Economic Commission. According to Chinara Mambetaliyeva, the EEC eagerly supported an event that would promote high pharma manufacturing standards based on best practice across the EAEU. ‘This will significantly further the competitive advantage of the EAEU pharma industry in the global market’, she pointed out. ‘Today, it is particularly important to work together toward fulfilling the industry’s innovation potential as a whole, and this gives even more weight to such projects. By unlocking professional competencies and implementing top innovative solutions across the industry, we facilitate its growth, foster major breakthroughs in the EAEU economies and encourage the expansion of the common pharmaceutical market. Contests like GxP-Profi help identify innovation leaders in quality assurance and build trust with the EAEU manufacturers’, added Chinara Mambetaliyeva. On behalf of the EEC, she expressed hope that the experience accumulated at this event would get traction, fully appreciated by the industry and eventually put into practice.
Prof. Irina Spichak, Doctor of Pharmaceutical Sciences and Executive Director of the Eurasian Academy of Good Practices, identified the four key tasks that GxP-Profi helps solve.
Firstly, it is about advancing the industry’s innovation-driven development in ensuring the quality of processes, operations and products. ‘Russian pharma has its leaders, and quite worthy at that’, believes Irina Spichak. ‘Our goal was to let the pharmaceutical manufacturers – and the entire country – see how hard they work toward quality assurance and how much energy and human capital it takes’.
Secondly, the event has made it possible to promote best practices for the first time. The organizers were able to see that with all the competition, pharma companies are willing to showcase their achievements. As for those enterprises that are at the very start of their growth, this experience can help them find a new development trajectory.
Thirdly, the contest is a stimulus for transformative development of human capital. ‘Pharma manufacturing employs very creative and talented people, which the GxP-Profi entries have indeed confirmed’, noted Irina Spichak. ‘Participation in the contest is a chance to incentivize the staff to better themselves and come up with new ideas’.
And finally, GxP-Profi helps solve a very important social task – overcoming the domestic consumers’ commitment to international drugs. Experts agree that it is time we changed this trend and instead paid more attention to domestically-produced medicines, which are just as good.
A total of 21 pharma companies from Russia, the EAEU and other countries participated in the 2022 GxP-Profi edition. All the contest entries included innovative solutions which were designed to improve the quality system at a pharma enterprise, and implemented with proven success. The areas covered in the projects spanned from digitalization to pharma engineering.
The contest consisted of two rounds. For the first – qualification – round, held from 1 July to 3 October, the teams submitted de-identified project descriptions for expert review. That guaranteed confidentiality and objectivity of judging. The expert committee comprising 10 people featured representatives of the Ministry of Industry and Trade, the State Institute of Drugs and Good Practices, the EEC, as well as leading industry experts.
A total of 10 best projects got through the qualification round. Companies such as Akrikhin, Biocad, Valenta Pharm, Geropharm (two entries), Minskintercaps, Polysan, Sotex, R-Pharm, and Pharmasyntez all made it to the finals.
In the final round held on 1 November, the teams presented their innovative solutions in front of the expert committee, and answered their questions.
According to Irina Spichak, selecting the three best projects was extremely hard. Each entry was judged on how innovative the solution was, and on its scope, elaboration and importance for quality assurance in pharma manufacturing. Other criteria included proven economic efficiency and improved social performance in the company’s quality system management.
‘The competition was tough. In fact, each of the finalist projects deserves the highest praise. We are proud of the professional excellence the participants have demonstrated’, commented Irina Spichak before revealing the results of the contest.
The first prize was awarded to Akrikhin's Data Integrity. From Good to the Best! project.
The solution is aimed at developing a data integrity system with the use of digital innovations. It meets the current international requirements for a variety of areas and processes, which all have an impact on the quality, effectiveness and safety of medicines. ‘Providing reliable data is an important component of a manufacturer's responsibilities, while the degree to which you can ensure data integrity reflects how successfully the enterprise is managed and the product quality control is ensured’, explained Elena Kasakina, Vice-President for EAEU Production Operations at Akrikhin.
The winner’s innovation was in its risk-oriented approach to data integrity that complies with the latest international requirements. This helped optimize the distribution of resources, identify potential sources of errors that could amplify the risks for the data integrity system throughout the lifecycle, and avoid wasting too much time on non-critical elements. Akrikhin took a whole set of measures designed to streamline its data integrity system, and digitalize the key QS and manufacturing processes. One focus area was working with the employees’ attitude to data integrity. The solution also showed consistent economic efficiency at every stage of its implementation.
Elena Kasakina believes that all the pharma market players today are facing crucial tasks, such as substituting imports, expanding production and fostering the development of innovative medicines. ‘Thanks to the constantly evolving pharma industry, we can provide a big part of the population with necessary drugs, and, consequently, make their lives healthier and longer’, said Elena Kasakina. ‘GxP-Profi is a great opportunity and platform for unlocking the potential of the pharmaceutical industry through development and implementation of GxP innovations’.
R-Pharm's Automation of Pharma Quality System Management came second.
R-Pharm's own Electronic Document Management System for Pharmaceutical Quality System (EDMS PQS) is based on a domestic business automation tool. ‘Having considered a number of out-of-the-box solutions by various software developers, we realized that none of them met our demands, and decided to create our own system. It represents a set of interrelated modules, each managing the whole lifecycle of electronic documents in every automated process’, explained Tatyana Vyazmina, Quality Director at R-Pharm.
The solution helps save human resources in R-Pharm’s QMS, boost effectiveness and facilitate control and monitoring. Moreover, this project allows for better transparency and data traceability in automated processes, reduces data integrity risks, makes resource distribution more flexible, and cuts down on expenses, such as buying paper, printers, spare parts and supplies. Besides, R-Pharm’s EDMS is integrated with other information systems, creating a single digital ecosystem for the group of companies’ pharmaceutical QS.
According to Tatyana Vyazmina, GxP-Profi has a particular importance for the industry as a whole because it enables all the Eurasian states to share their experience.
The third prize was awarded to Pharmasyntez's Utilities & Solutions for Manufacturing Hazardous Drugs in Compliance with the Current Regulations.
As part of the Pharma-2020 national program and with the support of the Ministry of Industry and Trade and the Government of the Tyumen Region, an enterprise was established at Pharmasyntez-Tyumen. One of Europe’s largest and Russia’s only production of its kind so far, it manufactures a wide range of hormonal drugs for hormone replacement therapy, oral contraception and treatment of gynecological endocrine disorders. Full-scale commercial operation is to be launched in the first quarter of 2023.
According to analytics agencies, about 95% of hormonal drugs in the Russian market are imported. It is estimated that in 3–4 years, once the enterprise is fully operational, the imports will occupy a ½–⅓ of its current share. The output of hormonal drugs is expected to surpass 35 international nonproprietary names, i.e. more than 5mn packages per year.
For Oleg Astafurov, Vice-President for GR at Pharmasyntez, the key feature of the project is related to the fact that hormonal drugs are classified as hazardous. This requires specific engineering solutions, high-priced complex manufacturing equipment, and an advanced quality and safety management system, which has been a deterrent to import substitution in this area for many years.
The Pharmasyntez Group of Companies joined by Pharmasyntez-Tyumen’s lead specialists were able to develop and implement a suite of engineering solutions that made it possible to create a high-performance enterprise producing a wide range of hormonal drugs. Built almost from scratch, and within a short period of time that coincided with the coronavirus pandemic, it conforms to all the environmental protection and staff safety requirements, as well as strict GMP regulations. A total of over RUB 4.5bn were invested in the project.
Oleg Astafurov believes that the 2022 edition of GxP-Profi has proved to be very exciting and useful for the company.
Summing up, Vladislav Shestakov said: ‘All the participants have come a long way and acquired new experience. We have become aware of a huge potential for switching to an innovative business model across the country. For that, it is important to promote best practices and encourage outside-the-box thinking’. The award ceremony will take place on 2 December. It will honor the winners and all the teams who have made it to the finals. Moreover, some projects will receive special prizes from the partners.
The participants to the press-conference are looking forward to the 2023 edition of GxP-Profi, expecting it to draw the attention of an even bigger number of pharma companies across the EAEU.