Application Of Quality Risk Management In Production Management Of Tablet Preparation

Quality risk management is a new requirement added to the 2010 version of the GMP specification,which stipulates that pharmaceutical companies establish quality risk management procedures for how to prevent pollution and cross-contamination,supplier management,product recovery and reprocessing,verification and confirmation,deviation management,prevention of quality risk management tools with corrective measures,change management,clean plants and facilities to control the overall risk of drugs and ensure the safety and effectiveness of drugs.With the joining of ICH in our country and the revision of the Drug Administration Law,no matter from the management level or the regulatory level,the quality risk management of pharmaceutical production has become more and more important in the management and management activities of pharmaceutical companies.I discovered the following difficulties in the exploration process of my company’s quality risk management:(1)Use more traditional risk management tools to diversify the contents of risk management and fail to form systematic documents to guide the rational allocation of management resources in production management to guide the continuous improvement of the quality management capabilities of pharmaceutical production.(2)In the process of risk identification,risk items are easily missed.(3)When conducting a risk assessment of the production management of marketed drugs,it is susceptible to interference by the existing management measures on the judgment of the degree of risk,resulting in misjudgment.In view of the above difficulties,this article takes the management of a traditional Chinese medicine tablet A product in the tablet production process as the research object,and adopts the method of combining work flow analysis and failure mode and impact analysis to affect the quality of each event element in the tablet production workflow.Elements for analysis.A total of 119 risk characteristics were identified,including 74low-risk items,36 medium-risk items,and 9 high-risk items.Through the identification and evaluation of different levels of risk,the above difficulties are overcome,which provides a basis for adopting effective methods that can be implemented.Through the research on the quality risk management of product A in the production process of tablets,explore the use of appropriate risk management tools in production management to carry out quality risk analysis and evaluation,and provide a way for the use of quality risk management tools in pharmaceutical production management.Effective and feasible method.