Forming a target quality product profile as the basis for pharmaceutical development of injectable drugs

Introduction. This article substantiates the need to form a target quality profile during the development of an injectable dosage form, which carries a high level of risk to patient safety due to the peculiarities of parenteral administration, where the drug directly enters the internal environment of the body, bypassing physiological barriers. Quality Target Product Profile (QTPP) indicators serve as a starting point for identifying critical quality attributes, conducting risk analysis, and developing a control strategy, thereby ensuring a systematic and regulatory-based approach to quality management of injectable drugs at all stages of their life cycle. The aim of the study is to analyze and systematize regulatory and methodological approaches to the formation of QTPP as a key element of pharmaceutical development of injectable drugs. Materials and methods. To visualize and structure the factors influencing the formation of quality indicators of injectable drugs within the framework of the QbD concept, the Ishikawa diagram was used. This tool made it possible to reflect the cause-and-effect relationships of the influence of factors of composition, technology, equipment, packaging, and production conditions on achieving the target quality profile of the drug. Results. The analysis of regulatory documents of the Russian Federation, the Eurasian Economic Union, and international regulatory organizations shows that modern requirements for the pharmaceutical development of injectable drugs are increasingly focused on a risk-oriented and scientifically sound approach, embedded in the QbD concept. At the same time, the entry into force of Recommendation No. 30 of the Collegium of the Eurasian Economic Commission dated November 11, 2025, reflects the transition from a predominantly conceptual application of QbD principles to their more explicit regulatory consolidation, including the direct use of the term target quality profile of a medicinal product. The use of a cause-and-effect diagram (Ishikawa diagram) in the analysis of quality indicators of injectable drugs has proven its effectiveness as a tool for systematizing factors influencing the achievement of QTPP. The Ishikawa diagram allows for a visual representation of the relationship between the properties of the active pharmaceutical ingredient, excipients, technological process, sterilization, and other parameters. Conclusion. The research results confirm that QTPP should be considered not only as a formal element of pharmaceutical development, but also as a universal tool for integrating clinical, technological, and regulatory requirements. The systematic application of this approach is especially important for injectable drugs, for which early and justified quality management is a critical factor for successful development, registration, and marketing.