Study of prospects and analysis of peculiarities related to introducing GMP standards in the Russian Federation
Bekhorashvili N., Rayisyan M. G.
Journal of Pharmaceutical Sciences and Research
Vol.10, Issue6, P. 1369-1372
Опубликовано: 2018
Тип ресурса: Статья
Аннотация:
The article analyzes the current state and problems related to introducing international GMP standards in the pharmaceutical sector of the Russian economy. The characteristics of the system of international GMP standards are given. The stages of introducing GMP standards into the Russian pharmaceutical practice are considered. Based on the expert survey, the activity of the Federal Budgetary Institution State Institute of Drugs and Good Practices (hereinafter – the FBI SID & GP), the authority inspecting medicines’ manufacturers, has been analyzed in terms of its compliance with GMP standards. It is concluded that the introduction of GMP standards will have positive impact on the quality of medicines on the Russian pharmaceutical market. © 2018, Pharmainfo Publications. All rights reserved.
Ключевые слова:
GMP standards; Medicines; Pharmaceutical sector of economy
Article; aseptic filling; cleaning; drug industry; drug manufacture; drug packaging; drug quality; drug stability; drug sterility; good manufacturing practice; microbial contamination; quality control; Russian Federation; validation process
Язык текста: Английский
ISSN: 0975-1459
Bekhorashvili N. Nana 1981-
Rayisyan M. G.
Бехорашвили Н. Нана 1981-
Райисян М. Г.
Study of prospects and analysis of peculiarities related to introducing GMP standards in the Russian Federation
Текст визуальный непосредственный
Journal of Pharmaceutical Sciences and Research
Vol.10, Issue6 P. 1369-1372
2018
Статья
GMP standards Medicines Pharmaceutical sector of economy
Article aseptic filling cleaning drug industry drug manufacture drug packaging drug quality drug stability drug sterility good manufacturing practice microbial contamination quality control Russian Federation validation process
The article analyzes the current state and problems related to introducing international GMP standards in the pharmaceutical sector of the Russian economy. The characteristics of the system of international GMP standards are given. The stages of introducing GMP standards into the Russian pharmaceutical practice are considered. Based on the expert survey, the activity of the Federal Budgetary Institution State Institute of Drugs and Good Practices (hereinafter – the FBI SID & GP), the authority inspecting medicines’ manufacturers, has been analyzed in terms of its compliance with GMP standards. It is concluded that the introduction of GMP standards will have positive impact on the quality of medicines on the Russian pharmaceutical market. © 2018, Pharmainfo Publications. All rights reserved.