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Improving the risk management process in the input control of raw materials used in the production of medicines

https://doi.org/10.32686/1812-5220-2023-20-1-78-86

Abstract

The article presents the rationale for the development of a set of measures that contribute to the improvement of the risk management procedure during the input control of raw materials and materials entering the pharmaceutical enterprise. The main methods and features of risk management during the input control of raw materials and materials entering the pharmaceutical enterprise are considered. The results of the risk analysis at the entrance control at the pharmaceutical enterprise are presented, the ranking of the identified risks according to the degree and probability of occurrence is carried out. Recommendations are formulated to improve the risk management process during the input control of raw materials used in the production of medicines.

About the Authors

P. V. Shefatov
PJSC “Kraspharma”
Russian Federation

Pavel V. Shefatov

60 let Oktyabrya str., 2, Krasnoyarsk, 660042



A. S. Orlov
Saint-Petersburg State Chemical and Pharmaceutical University
Russian Federation

Alexander S. Orlov

Professora Popova str., 14, St. Petersburg, 197022



References

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3. Decision of November 3, 2016 No. 77 “On the approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union” [Electronic resource. Access mode: https://docs.cntd.ru/document/456026099, (In Russ.)

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6. Kartvelishvili V. M. Risk management. Risk assessment methods: textbook / V. M. Kartvelishvili, O. A. Sviridova. Moscow: FSBEI HE “REU named after G. V. Plekhanov”, 2017. 120 p., (In Russ.)

7. GOST R ISO 31000-2010/ISO 31000:2019 Risk Management. Principles and guidance. M.: Standardinform, 2020 [Electronic resource. Access mode: https://docs.cntd.ru/document/1200170125, (In Russ.)


Review

For citations:


Shefatov P.V., Orlov A.S. Improving the risk management process in the input control of raw materials used in the production of medicines. Issues of Risk Analysis. 2023;20(1):78-86. (In Russ.) https://doi.org/10.32686/1812-5220-2023-20-1-78-86

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ISSN 1812-5220 (Print)
ISSN 2658-7882 (Online)