Risk analysis for the definition of representative drug for the formation of the quality review at the pharmaceutical enterprise
Keywords:
the risks analysis, HACCP, FMEA, quality review
Abstract
A method for efficient use of resources in formation of the quality review of product in the pharmaceutical company based on a selection of the representative drug is developed. By the risk analysis methods HACCP "Hazard Analysis and Critical Control Points" and FMEA "Procedures for failure mode and effects analysis" identified potential hazards and the proposed ranking algorithm to select a representative drug. The procedure will reduce the amount of resources involved in the formation of the quality review without compromising the objectivity of its results.
References
1. "Instruction. Medicines. Good manufacturing practice. ST-N MOHU 42-4.0: 2011 ". - K., 2011.
2. Popov A.Yu., Meshkovsky A.P. Risk Analysis System (HACCP) as the first step in the transition to work according to the rules of proper industrial practice (GMP) // Pharmamatka. - 2002. - No. 4. - P. 62-64.
2. Popov A.Yu., Meshkovsky A.P. Risk Analysis System (HACCP) as the first step in the transition to work according to the rules of proper industrial practice (GMP) // Pharmamatka. - 2002. - No. 4. - P. 62-64.
Published
2019-03-18
How to Cite
Shkliaiev, S. (2019). Risk analysis for the definition of representative drug for the formation of the quality review at the pharmaceutical enterprise. Farmatsevtychnyi Zhurnal, (6), 26-29. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/563
Section
Risk Analysis at a Pharmaceutical Enterprise
This work is licensed under a Creative Commons Attribution 4.0 International License.
