Application of Three-stage Quality Management in Drug Development
This paper compares and analyzes the limitations of two-stage quality management and four-stage quality management,studies the advantages of three-stage quality management,and takes the implementation of three-stage quality management in non-clinical research module of a micro-ecological viable bacteria pharmaceutical company as a practical case.After the implementation of the three-stage quality management,the deviation rate of the scheme decreased from 60%to 25%.Through the questionnaire survey,the results show that 70.59%of employees believe that the three-stage quality management has a greater role in promoting their own work,and the implementation of the three-stage quality management has achieved good results.Based on this,this paper analyzes the feasibility and application of three-stage quality management in the quality management of pharmaceutical enterprises,and provides reference for pharmaceutical enterprises to improve the quality management level of R&D.
pharmaceutical enterprisesdrug research and developmentthree stages of quality managementrisk management
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