Modern trends in the implementation of the concept of quality assurance of medicines in Ukraine
Journal Title: Фармацевтичний журнал - Year 2014, Vol 4, Issue 4
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.
Authors and Affiliations
О. P. Baula, I. S. Chekman, A. O. Syrovaya, S. N. Kovalenko, N. Gorchakova, О. L. Levashova
Keywords
Related Articles
- EP ID EP588089
- DOI -
- Views 77
- Downloads 0
Analysis of drug group D07 «Corticosteroids for use in dermatology» on the Ukrainian pharmaceutical market
In some cases, ringworm, accompanied by inflammatory reaction of skin treated with combined administration of antifungal drugs and corticosteroids local action. In Ukraine there is an unequal distribution of the producti...
Development and validation of the method quantitative determination of enisamium iodide for the assessment of dissolution profile of antiviral agent
Assessment of the dissolution profiles is an important tool for characterization of solid drug products which need to be examined both at the stage of pharmaceutical development, and throughout their life cycle. It is ne...
Synthesis of series S-5-R-4-R1-4H-1,2,4-triazol-3-ilsulfonthioates and investigation of their further oxidation
hemistry of 1,2,4-triazole attracts both domestic and foreign researchers due to the fact that, based on this heterocycle created substances widely used in various spheres of life . Widely studied synthetic, physical-che...
Special aspects of biosimilars as an object of intellectual property
Main factors of the development of biosimilars market are their high efficiency, the availability of evidential base, a reasonable price compared to the original products, broad field of application, the social importanc...
Tail-flick-est – aspects use in pharmacological researches
The adequate assessment of anti-nociceptive activity is important. This is necessary for development of new analgesics that exceed effectiveness and/or safety of existing analgesics, fundamental research, study specifics...