РАЗРАБОТКА И РЕГИСТРАЦИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ. 2022. Т. 11, № 1 DRUG DEVELOPMENT & REGISTRATION. 2022. V. 11, No. 1 Aim. Development of a scientifically based program and methodology for cross-contamination risk management for existing pharmaceutical
industries, taking into account compliance with the harmonized GMP requirements of the Russian Federation and the EAEU and world practice.
Materials and methods. In the course of the study, methods of risk management, analysis and systematization of data and a process approach
were used.
Results and discussion. The key aspects of the organization of the co-manufacturing of medicines are outlined. A step-by-step approach to
risk management, involving a preliminary assessment of the conformity of a production organization with GMP requirements is described. The
proposed scheme is aimed at ensuring the continuous functioning of the cross-contamination risk management process.
Conclusion. The presented risk management methodology aims to conduct a proper assessment of the risks of cross-contamination for multi-
product pharmaceutical enterprises. This technique allows to identify areas that need improvement to ensure compliance of manufacturing sites
with GMP requirements, which ultimately contributes to improving the quality of medicines.
Keywords: quality, quality assurance, cross-contamination, risk, risk management, pharmaceutical manufacturing
Conflict of interest. The authors declare that they have no obvious and potential conflicts of interest related to the publication of this article.
Contribution of the authors. Anna A. Dzerzhinskaya planned the research, analyzed information materials and processed the results. Alexandra A.
Spiridonova and Elena G. Khomutova edited and analyzed the materials. All authors took an active part in discussing the results and writing the
text of the article.
