General characteristics of GMP (Good Manufacturing Practice)and some questions about the usage of terminology

Abstract

The problem of emergence of the illegal pharmaceutical products is generally recognized and relevant for the all developing countries. In this case, the risk of such products increases in proportion to the total pharmaceutical market.The basic ideas of the quality assurance, good manufacturing practices (GMP), quality control and risk management for the quality are interrelated. Abroad are published a lot of literature on the topic of GMP, which was written by former inspectors of the supervising bodies are published, but in Russian there is a lack of such literature, which complicates understanding. This article provides a brief, general description of the system of GMP (Good Manufacturing Practice) for the pharmaceutical industry, in accordance with the international experience and the current legislation of the Russian Federation. An approach to the definition of unsafe medicines in the United States is discussed. This circumstance is the need to optimize the system of preventing the production and trafficking of counterfeit drugs and topical issues of the terminology used in a potentially dangerous drug, in the Russian Federation.