Risk management for quality assurance of preclinical research
Abstract
The article discusses various aspects of risk management for quality assurance (QA) of preclinical studies of drugs. The authors analysed risk management methods and approaches, and defined relevant risk management methods to be used in preclinical studies performed according to ISO 9001 and the Good Laboratory Practice principles. The article highlights the need for holistic risk management to ensure the reliability and safety of further preclinical research. The selection of a risk assessment method should be based on the analysis of the preclinical organization’s needs. The risk management activities should result in a system of corrective and preventive actions which aim to reduce risks and to assure regular monitoring.
About the Authors
E. D. Burova
Saint-Petersburg Institute of Pharmacy
Russian Federation
Russian Federation
S. V. Khodko
Research-and-Manufacturing Company «HOME OF PHARMACY
Russian Federation
Russian Federation
S. V. Gushchina
Research-and-Manufacturing Company «HOME OF PHARMACY
Russian Federation
Russian Federation
M. N. Makarova
Saint-Petersburg Institute of Pharmacy
Russian Federation
Russian Federation
V. G. Makarov
Research-and-Manufacturing Company «HOME OF PHARMACY
Russian Federation
Russian Federation
References
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Review
For citations:
Burova E.D., Khodko S.V., Gushchina S.V., Makarova M.N., Makarov V.G. Risk management for quality assurance of preclinical research. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(1):25-32. (In Russ.)
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