Introduction. All manufactured medicinal products must correspond Rules of Good Manufacturing Practice (GMP), which cover all aspects of production: from raw materials, facilities and equipment to personal hygiene and staff training. Acetylsalicylic acid is one of the most common drugs and is used in medical practice as an antiinflammatory, antipyretic, analgetic, antiplatelet agent. Acetylsalicylic acid is included in the standards of treatment for patients suffering from cardiovascular diseases, coronary heart disease, which indicates the demand for this drug, despite many years of experience in its use. The most common dosage form of acetylsalicylic acid are tablets produced by various pharmaceutical companies. The aim. The aim of our research was the analysis of the production process of acetylsalicylic acid tablets and intermediate stages of their quality control for compliance with the requirements of regulatory documents based on a risk-based approach. Materials and methods. To achieve this goal, a study was conducted, including logical and system analysis. The method of Hazard Analysis and Critical Control Points (HACCP) was used to identify risks. The object of the study was the process of production and quality control of acetylsalicylic acid tablets, taking into account critical points at all stages of the product life cycle. Results. The study of the production process of acetylsalicylic acid tablets was carried out. A register of risk factors has been formed and risks have been identified in the production of acetylsalicylic acid tablets, a qualitative analysis of the consequences of the implementation of risks and an assessment of their probabilities have been carried out, the degree of influence of risks on the quality of the products obtained has been established, recommendations for risk management in the production of acetylsalicylic acid tablets have been determined. Discussions. At the first stage of the study, risks were identified, at the second stage, the probability of occurrence of events and the severity of the consequences were assessed, followed by determination of the level of risk. Conclusion. The analysis of the production process of acetylsalicylic acid tablets and intermediate stages of their quality control for compliance with the requirements of normative documents was held on based on a risk-based approach. Risks at the tableting stage in the production of acetylsalicylic acid tablets were identified by the method of Hazard Analysis and Critical Control Points (HACCP). The criteria of probability of exposure to risk and severity of consequences of exposure to risk at the tableting stage were formulated and estimated.