Application Of Quality Risk Management Of API Products Of Company T Based On Fmea And FTA

The quality of drugs is the core competitiveness for enterprises.The increasingly competitive market of active pharmaceutical ingredients(APIs)and the complexity of the pharmaceutical production process determine that strengthening the quality risk management is of great significance in the production process of the company.In recent years,drug regulatory agencies at home and abroad have increasingly emphasized the importance of quality management concepts.In this thesis,the production process of API product M in company T is studied.The purpose is to correctly predict and estimate the quality of the products,and to find out the root causes of the quality problem,and then to reduce the variation and potential loss in the production,to achieve the purpose of improving pharmaceutical quality,and increasing economic efficiency.This thesis designed the failure mode table,the implementation steps of the failure mode and the 10-grade assessment criteria of severity,degree of occurrence and degree of detection for failure mode and effects analysis(FMEA)during the manufacturing process of APIs.The design is based on the in-depth study of the theory of fault tree analysis(FTA)and FMEA,and targets the characteristics of API products.Besides,according to the assessment of risk priority number,FTA analysis is conducted on the failure mode to find the root cause of the problem.Effective measures are then implemented.The comprehensive analysis involving FMEA and FTA in this study is applicable to API products.This thesis utilizes the API product M from company T as an example,through the use of FMEA and fishbone diagram analysis,established the failure mode table for product M.Then the key failure,namely reaction temperature and time overrun,were selected as examples to conduct FTA an as top events.Through qualitative and quantitative analysis,two terminal factors were found and targeted improvement schemes were proposed.As a result the comprehensive implementation of FMEA and FTA has significantly improved the production economy of API product M,improved the stability of the product quality,and improved the production yield,thus bringing the enterprise millions of yuan of income.The analysis solved the quality problems faced by company T,and provided other API companies with supports and references for their quality risk management.