Systematic approach to cross-contamination risk management
in the production of medicinal products
Anna A. Dzerzhinskaya
1
*, Alexandra A. Spiridonova
2
, Elena G. Khomutova
2
1
Federal State Unitary Enterprise "Moscow Endocrine Plant", 25, Novokhokhlovskaya str., 109052, Russia
2
Federal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University", 86, Vernadsky av., Moscow, 119571, Russia
*Corresponding author:
Anna A. Dzerzhinskaya.
E-mail:
dzerzhinskaya@gmail.com
ORCID:
Anna A. Dzerzhinskaya – https://orcid.org/0000-0002-6252-2619; Alexandra A. Spiridonova – https://orcid.org/0000-0001-7601-1281;
Elena G. Khomutova – https://orcid.org/0000-0001-7467-8939.
Received:
30.08.2021
Revised:
28.01.2022
Published:
25.02.2022
Abstract
Introduction.
Good Manufacturing Practice (GMP) requires drug manufacturers to apply risk management principles in their operations. One of
the main risks to the quality and safety of pharmaceuticals is cross-contamination. The introduction of a systematic approach to contamination
risk management requires manufacturers to make a comprehensive assessment of both production processes and the organization of production
sites (premises, equipment, systems, etc.). Therefore, the transition to the current GMP requirements for operating production sites may require
significantly higher financial and labor costs than for projected production facilities.
Регуляторные вопросы
Regulatory Issues
© Дзержинская А. А., Спиридонова А. А., Хомутова Е. Г., 2022
© Dzerzhinskaya A. A., Spiridonova A. A., Khomutova E. G., 2022
150
Достарыңызбен бөлісу: |
