As part of the All-Russian Scientific and Practical Conference with International Participation "Pharmaceutical Science: Challenges and Solutions in the 21st Century," a section was held dedicated to the practical implementation of pharmaceutical chemistry in the track of R&D, standardization, and quality control. The moderators, Elena Sakanyan and Inna Terninko, outlined the key topic of discussion: ensuring the quality of medicines at all stages of their life cycle.
Opening the section, Elena Sakanyan examined issues of drug standardization at the development stage and subsequent circulation. Special attention was paid to the principles of Quality by Design, requirements for active pharmaceutical ingredients and excipients, as well as the justification of quality attributes and control of incoming raw materials. It was emphasized that the development stage determines the future safety and efficacy of the drug.
The discussion on quality issues of herbal medicinal products was continued by Irina Gravel, who presented research on the microelement profiles of medicinal plant raw materials. She demonstrated the influence of raw material origin and manufacturer on elemental content, as well as the necessity of controlling toxic impurities and assessing their concentrations in multicomponent products.
Roman Lukashov addressed the issues of plant raw material identification, noting the limitations of traditional pharmacognostic methods. Chromatographic profiles and molecular genetic approaches were considered as promising solutions, enabling increased analytical reliability and the detection of foreign impurities.
The specifics of obtaining and controlling radiopharmaceuticals were presented by Maria Larkina and Mikhail Belousov. It was noted that the particular nature of such drugs requires special quality control schemes, including the conduct of separate tests after product release.
The issue of analytical method transfer for herbal preparations was highlighted by Ifrat Zilfikarov, who emphasized the importance of correct documentation, personnel training, and risk assessment when transferring methods between laboratories. Transfer is seen not only as a regulatory procedure but also as a tool for improving quality control.
Practical aspects of drug stability studies were examined by Inna Terninko using real-life case studies, showing the impact of storage conditions, analytical methods, and study programs on confirming drug safety.
Environmental issues of pharmaceutical production were addressed by Nadezhda Mikhailova, who outlined the problem of antibacterial substances entering the environment and the need to develop approaches for the neutralization of pharmaceutical waste.
Modern approaches to quality management of drug delivery systems were presented by Ulyana Efremova, describing the application of the Quality by Design concept and risk-oriented tools to determine critical quality attributes.
International experience in the standardization of plant raw materials was presented by Tolkyn Bekezhanova, who demonstrated an algorithm for screening the flora of Southern Kazakhstan, which allowed the identification of promising types of raw materials for full-cycle pharmaceutical production.
Problems in evaluating the effectiveness of solid dispersions were considered by Lada Ignatova, noting the absence of unified regulatory approaches to drug release testing.
The section was concluded by Aigerim Karaubaeva, who presented a methodology for the conceptual design of medicinal raw material processing using systemic, process-based, and risk-oriented approaches, allowing GMP requirements to be considered as early as the design stages.
The work of the section demonstrated that modern pharmaceutical science is evolving in the direction of end-to-end standardization, the integration of analytical technologies, and the strengthening of interdisciplinary interaction at all stages of drug development.