Analysis of Common Problems and Suggestions on Quality Risk Management of Biological Products Production
Objective:By reviewing the application history of quality risk management concepts in the pharmaceutical industry and the requirements in several countries'regulations,and collecting the problems found in the inspection of biological products manufactur-ers by multiple drug inspection agencies around the world,to analyze the common problems in the application of the concept of quality risk management in the production and quality management of biological products manufacturers,and provide suggestions to promote the more scientific use of quality risk management concepts in biological products manufacturers.Methods:Based on inspection reports from the World Health Organization,China and the United States drug inspection agencies,the contents related to quality risk assessment and control of biological products manufacturers in the aspects of quality management,organization and personnel,premises and facilities equipment,material and products,qualification and validation,documentation management,production management,quality control and quality assurance were classified and summarized,and analyzed to provide targeted suggestions.Results&Conclusion:The con-cept and tools of quality risk management have been widely used in various stages of the entire life cycle of biological products.However,there are still some problems in the application in production quality management,such as ineffective risk identification,incomplete risk assessment,insufficient control measures,and lack of regular review,which need to be gradually improved.This article proposes several suggestions to improve the quality management level of biological products manufacturers and ensure product quality,including integrat-ing the concept of quality risk management throughout the entire life cycle of biological products production management,participation of interdisciplinary personnel in quality risk management,enhancing in-depth understanding of quality risk management concepts,promot-ing better application,and so on.
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