Modern trends in the implementation of the concept of quality assurance of medicines in Ukraine

  • О. P. Baula Public Enterprise «The State Expert Center of the Ministry of Health of Ukraine», Kyiv
  • I. S. Chekman Bogomolets National Medical University, Kyiv
  • А. О. Syrovaya Kharkiv National Medical University
  • S. N. Kovalenko National University of Pharmacy, Kharkiv
  • N. A. Gorchakova Bogomolets National Medical University, Kyiv
  • О. L. Levashova Kharkiv National Medical University
Keywords: medicines, good manufacturing practice, quality system, pharmaceutical industry

Abstract

Given that the quality of pharmaceuticals is formed on the pharmaceutical development phase, proven during preclinical and clinical trials, estimated by the state registration, realized in the industrial production, and monitored at the stages of distribution and use, the need to ensure the functioning of all the stages based on common principles and rules rises. Domestic pharmaceutical industry has great potential, and as it is projected to subsequent years, it will be marked by a significant increase in production of pharmaceuticals, efficiency and quality of which will not be inferior to foreign analogues. This is confirmed by the fact that Ukrainian pharmaceutical companies have chosen the only right way – compliance with international standards at all stages of the life cycle of pharmaceuticals. The purpose of building such a system is the creation of joint subsystems documented quality management, environmental and occupational health, project management etc, as well as their adaptation to the corporate management of the company. Thus, the introduction of the pharmaceutical field of international standards and regulations will create an effective system of quality assurance of medicines in the interests of consumers, as well as implement effective technical barriers that are able to guarantee entry to the national market for only high quality medicines and to provide the real possibilities of accessing global pharmaceutical market for the domestic producers.

The article describes the current trends of Ukrainian pharmaceutical industry, the introduction of quality assurance at all stages of the life cycle of drugs, the principles and rules: Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Practice, Good Pharmacy Practice, Good Distribution Practice, Good Storage Practice.

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Published
2019-02-12
How to Cite
BaulaО. P., Chekman, I. S., SyrovayaА. О., Kovalenko, S. N., Gorchakova, N. A., & LevashovaО. L. (2019). Modern trends in the implementation of the concept of quality assurance of medicines in Ukraine. Farmatsevtychnyi Zhurnal, (4), 66-75. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/351
Section
Production, quality control, standardization of medicines