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

P. V. Shefatov, A. Orlov
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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.
改进药品生产原料投入控制的风险管理流程
本文介绍了制定一套措施的基本原理,这些措施有助于改进制药企业在原材料和进入药品的投入控制过程中的风险管理程序。分析了制药企业原料投入控制和原料进入风险管理的主要方法和特点。给出了制药企业入口控制风险分析的结果,并根据风险发生的程度和概率对已识别的风险进行了排序。制定了建议,以改进在药品生产中使用的原材料投入物控制期间的风险管理过程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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