As we welcome Grygoriy Luchentsov as the new Director of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, we also take a moment to pay tribute to Oleksandr Gryzodub, whose leadership from December 2005 until February 2024 has been instrumental in shaping the success and reputation of our institution.
Under Oleksandr's guidance, the Center has achieved remarkable milestones, advancing the standards of quality in the pharmaceutical field. His vision has not only guided us through significant challenges but also paved the way for groundbreaking research and innovation. Oleksandr's dedication to excellence has left an indelible mark on our organization, inspiring colleagues and partners alike.
Oleksandr Gryzodub led the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines for more than 18 years, during which his leadership brought significant changes to the structure and principles of the center's operation. These changes include:
1. Financial and economic work concept of work: At the time of Oleksandr’s appointment, the center was on the brink of bankruptcy due to the loss of the main source of funding. However, thanks to his decisive actions and the adaptation of the USP model, the center not only managed to emerge from the crisis but also significantly increased its revenues and efficiency, in particular through the certification of pharmacopeial reference standards, the sales of which increased 200 times over the period 2005-2023, and the share from their sales in net income – from 9% to 74%. This made it possible to eliminate the debt and increase the average salary by 3.5 times (in dollar equivalent) while doubling the number of employees. The developed financial and economic model allowed the enterprise to develop the State Pharmacopoeia of Ukraine (SPhU) even in the absence of state funding while paying taxes, which is unique.
2. Administrative structure: The introduction of significant autonomy of administrative divisions and the widespread use of online modes of operation have greatly enhanced the centre's operational efficiency, especially during COVID and wartime conditions, allowing not only to quickly resume work but also increase the number of services provided by the enterprise and, accordingly, income.
3. Scientific activity: The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines has become a leading center for standardization and metrology in the field of pharmacy in the post-Soviet space. Thanks to the involvement of highly qualified specialists, the center has developed scientific directions on the quality of medicinal products, including chromatography, validation, reference standards, metrological support, bacterial endotoxins, microbiological purity, etc. The company’s significant scientific potential allows solving all tasks related to the development, maintenance, and improvement of an efficient system of standardization, metrology, and quality assurance of medicinal products.
- State Pharmacopoeia of Ukraine (SPhU)
The primary task of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines is the creation and support of the SPhU harmonized with leading global pharmacopoeias. From 2005 to 2024, the system of work on the SPhU underwent significant changes, in particular, through the elimination of expert commissions and the choice of scientific directions, the management of which involved not only the center's employees but also leading specialists from academia and industry. This facilitated not only the simplification of the SPhU development but also the advancement of science in higher education institutions and enterprises. During this period, 12 volumes of the SPhU were put into effect, and another 2 volumes have been prepared for publication. The SPhU has been recognized as the best national pharmacopoeia in the post-Soviet space, which in 2013 allowed Ukraine to become a valid member of the European Pharmacopoeia (Ph.Eur.).
- National System of Pharmacopoeial Reference Standards (RSs)
Thanks to extensive systematic scientific research, the center has developed a unique National System of pharmacopoeial RSs, which has become a key element in ensuring the quality of medicinal products in Ukraine. In addition, the existence of this system allows domestic developers, manufacturers, and quality control laboratories to save foreign currency funds significantly. Currently, the SPhU RSs are internationally recognized and rank 6th in terms of the nomenclature among other world pharmacopeias.
- Pharmacopoeial Professional Testing (PT) Program
The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines has created a unique pharmacopoeial PT program in the world, which serves as feedback between the SPhU and pharmaceutical enterprises, allowing for monitoring and enhancing the level of professionalism of quality control laboratory specialists in Ukraine. This system has become the basis for the development of metrological assurance of the quality of medicinal products, which is critically important for the integration of Ukrainian enterprises into the EU market.
- Quality Control of Medicines
The Laboratory of Pharmacopoeial Analysis (PhAL), established at the centre, is the first high-professional control laboratory that largely determines the level of pharmacopoeial quality control in Ukraine. PhAL is the only laboratory in Ukraine engaged in the development of pharmacopoeial control methods for bacterial endotoxins and is also a leader in microbiological control issues.
4. International Activities
The international activity of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines plays a key role in ensuring high standards of quality for medicinal products at the national level and integrating the Ukrainian pharmaceutical system into the global space. This has been made possible by a number of important steps and achievements made under the leadership of Oleksandr Gryzodub:
- Вступ України до Європейської Фармакопеї (Ph.Eur.): ДП «Фармакопейний центр» сприяв інтеграції України в Ph.Eur., що є значним досягненням, оскільки членство в Ph.Eur. забезпечує доступ та гармонізацію фармакопейних стандартів якості з країнами Європейського Союзу. Це також підвищує рівень довіри до українських фармацевтичних продуктів на міжнародному ринку.
- Ukraine's Entry into the European Pharmacopoeia (Ph.Eur.): The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines contributed to Ukraine's integration into Ph.Eur., which is a significant achievement as membership in Ph.Eur. provides access to and harmonization of pharmacopoeial quality standards with the countries of the European Union. This also increases the level of trust in Ukrainian pharmaceutical products on the international market.
- MoU with the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP): Signing agreements with the United States Pharmacopeia (USP) and the British Pharmacopeia (BP) is an important step towards harmonizing the quality standards of medicinal products in Ukraine with international norms. These agreements allow for the use of texts from these pharmacopoeias for the development of the State Pharmacopoeia of Ukraine (SPhU), ensuring its relevance and conformity to international standards.
- Cooperation with Leading Pharmacopeias and Committees of the Council of Europe: Employees of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines actively interact with leading pharmacopoeias of the world and committees of the Council of Europe; they are delegates of Ukraine in key intergovernmental steering committees of the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Pharmacopoeia Commission (EPC), the United States Pharmacopeial Convention (USP), the International Meeting of World Pharmacopoeias (IMWP), Expert Committees of the World Health Organization (WHO), and also members of working/expert groups of Ph.Eur., USP, WHO, and other leading world pharmacopoeias.
- Participation in International Standardization Organizations: Center employees take an active part in the work of the European Association for Metrology in Analytical Chemistry (EURACHEM) and other international organizations. This allows for the exchange of experience in the field of metrological assurance of the quality of analysis results and the implementation of the best global practices.
- Participation in International Conferences and Projects: Employees of the center actively participate in the work of international conferences and projects. Such collaboration facilitates the exchange of knowledge and experience, as well as ensures the implementation of advanced practices in the field of quality assurance of medicinal products in Ukraine.
Thanks to these measures, Ukraine has not only improved the quality of domestic medicinal products but also strengthened its position at the international level, becoming a full-fledged member of the international pharmaceutical community. Such integration ensures that Ukrainian standards for the quality of medicinal products meet global requirements, contribute to the development of the national pharmaceutical industry, and ensure the protection of public health.
In summary, Oleksandr Gryzodub made a significant contribution to the development of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, becoming an example of leadership and an innovative management approach. His efforts in implementing a new financial and economic model and adapting the administrative structure supported the center in difficult times and ensured its future prosperity. Under the leadership of Oleksandr Gryzodub, the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines became a leading center for standardization and metrology in the field of pharmacy. His efforts in developing key scientific directions, such as chromatography, validation, reference standards, metrology, etc., significantly enhanced the center’s scientific potential. This allowed for the creation of an effective system of standardization, metrology, and quality assurance of medicinal products in Ukraine.
Thanks to his outstanding leadership, the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines has achieved remarkable success in ensuring high standards of quality for medicinal products, implementing innovations and developing a scientific base, strengthening Ukraine's reputation as a leader in the pharmaceutical industry at the international level.
As Oleksandr transitions to the role of Chief Scientific Officer, we look forward to his continued contributions to our mission. His wealth of experience and profound knowledge will remain vital to our ongoing projects and future endeavours in this new capacity. Oleksandr is not just moving to a new position within our Center; he is continuing his journey of impact, steering our scientific research towards new horizons.
We wish to express our deepest gratitude to Oleksandr for his unwavering commitment and leadership over the years. His legacy is not only a testament to his personal achievements but also to the collective success of our team. As we embark on this new chapter, Oleksandr remains an invaluable part of our family, embodying the spirit of innovation and the pursuit of excellence that defines us.
Thank you, Oleksandr, for your remarkable leadership. Your contributions will always be a cornerstone of our institution's history. Here's to continuing to achieve great things together!
Concluding of the agreement with the US Pharmacopoeia, 2010
MoU Signing with the British Pharmacopoeia, 2013
Oleksandr Gryzodub with Roger Williams, the director of the US Pharmacopoeia, 2012
The delegation of Ukraine with Susanne Keitel, the director of the European Pharmacopoeia, 2012
The delegation of Ukraine with Ronald T. Piervincenzi, CEO at the US Pharmacopoeia, 2014
Oleksandr Gryzodub at the Meeting of World Pharmacopoeias, 2011
Oleksandr Gryzodub at a meeting of the European Pharmacopoeia Commission, 1998