Features of risk analysis, assessment and control methods in pharmaceutical development

Abstract

Quality Risk Management (QRM) is an important aspect of pharmaceutical development in the Quality-by-Design paradigm, since it determines the Design Space, critical quality attributes and critical process attributes. The purpose of this review is to systematize and analyze the main aspects of the QRM system in relation to each element of pharmaceutical development. This review article discusses the following key elements of QRM such as: risk analysis, risk control, risk communication, risk verification. For risk analysis, the advantages and disadvantages of QRM tools such as Preliminary Hazard Analysis, Failure Mode Effects Analysis, Fault Tree Analysis are presented and analyzed, Hazard Operability Analysis and Hazard Analysis and Critical Control Points. In addition, a description of the methods of mathematical planning and design of experiments for pharmaceutical development and QRM is given and their significance for these systems is determined. Elements of QRM such as root cause analysis, brainstorming, and a corrective and preventive action procedure are given as risk control and mitigation tools. In this paper, the main stages of QRM are considered and conclusions are formulated regarding the main advantages and disadvantages of the methods of identification, analysis, control, risk reporting, and the main ways for fur-ther improvement of the presented system are proposed.