Abstract
The study of quality assurance methods for medicinal products in Ukraine and other countries is relevant to the improvement and development of the pharmaceutical industry. The study aimed to compare the quality systems for the supply of medicines in Ukraine and abroad. The structural and logical analysis methods, as well as bibliosemantic and analytical-synthetic methods, were used in the study. The comparison was conducted by analysing documents issued in foreign countries by regulatory authorities, such as the Food and Drug Administration in the United States of America or the European Medicines Agency in Europe, which is substantial in ensuring the quality of medicines. In Ukraine, the State Service of Ukraine on Medicines and Drugs Control is a regulatory body. The analysis revealed several differences in the quality control systems for medicines in Ukraine and abroad. Good Manufacturing Practice standards are universally recognised for quality assurance in pharmaceutical production. Compliance with the standards is mandatory in Ukraine and abroad. Regular testing of medicines in authorised laboratories is crucial to ensure their safety and effectiveness. Ukraine, similarly to other countries, conducts quality control testing. Monitoring and reporting of adverse drug reactions after the sale is essential to identify and address safety issues. Although pharmacovigilance systems exist in Ukraine and abroad, there may be differences in terms of reporting requirements, infrastructure and resources allocated to pharmacovigilance activities. Scheduled inspections of production facilities and distribution channels are carried out to verify compliance with the rules. Educating healthcare professionals and the public about the importance of ensuring the quality of medicines contributes to informed decision-making. The analysis of the quality control of medicinal products suggests that the fundamental methods of quality assurance are similar around the world, while differences in the regulatory framework, resources, infrastructure and implementation may affect the efficiency and effectiveness of quality assurance measures between Ukraine and other countries. Collaboration, compliance with international standards and continuous improvement are essential to promote quality assurance practices in Ukraine and abroad
Publisher
Scientific Journals Publishing House