Objective To explore the current situation and countermeasures of deviation management in drug manufacturing enterprises,to provide reference for the deviation management of pharmaceutical manufacturers,and also to provide reference for the efficient inspection of deviation management in drug supervision and inspection.Methods Summarize and analyze the problems existing in the deviation management of pharmaceutical manufacturers,analyze the root causes of the problems and put forward corresponding countermeasures.Results The enterprise has logical problems in the identification and reporting process of deviation,insufficient deviation investigation,inadequate treatment of personnel error class deviation,unreasonable formulation of corrective and preventive measures,and lack of systematic scientific impact assessment.Conclusion Pharmaceutical manufacturers should attach importance to deviation management,continue to carry out deviation handling training at all levels,set up subject matter expert teams,attach importance to the handling of personnel error deviations,use appropriate quality risk management tools to carry out deviation investigation and impact assessment,identify the root causes of deviations,and help improve the quality management system of enterprises.
关键词
药品生产/药品监管/偏差管理/根本原因/风险评估/质量管理体系
Key words
pharmaceutical production/drug regulation/deviation management/root cause/risk assessment/quality management system
维普
万方数据