The monograph provides a detailed analysis of GMP rules. Fedotov Alexander Evgenievich, Doctor of Technical Sciences, President of the Association of Engineers for the Control of Micropollutants (ASINKOM), Editor-in-Chief of the journal "Technology of Purity," Chairman of Technical Committees for Standardization TC 184 "Ensuring Industrial Purity" and TC 458 "Production and Quality Control of Medicines. For many years he has been dealing with the problems of clean rooms, production organization and GMP rules.