Keywords: quality system, science-based information policy, organizational structure, inspection program, qualified personal.

Abstract

The quality system is the milestone of the pharmaceutical production. The quality specialists know how it is hard to create robust system and support its activity at the proper level. The size of the regulations increases with each year. However, the quality specialists do not see the clear ways to reach and realize it in practice despite the fact that a large quantity of standards and the instructions are going up. The real recommendations are absent. It is impossible to create actually working system snatching out the fragments from the standards, and realizing them in practice. Vital question, how to practically reach GMP compliance is the most urgent.

The present article gives the general elements of the GMP standards implementation in practise.

The article can be loaded in Russian in PDF format.