药品生产企业偏差管理的现状分析与对策

Analysis of the Current Situation and Countermeasures of Deviation Management in Pharmaceutical Manufacturers

目的 探讨药品生产企业偏差管理的现状与对策,为药品生产企业的偏差管理工作提供参考,同时也为药品监管检查工作中对偏差管理的高效检查提供借鉴。方法 总结分析药品生产企业偏差管理存在的问题,分析问题产生的根本原因并提出相应的对策。结果 企业在偏差的识别与上报流程上存在逻辑问题,偏差调查不充分,弱化人员差错类偏差的处理,纠正和预防措施制订不合理,影响性评估缺乏系统科学性。结论药品生产企业应重视偏差管理工作,持续开展各层级偏差处理培训,组建主题专家团队,重视人员差错类偏差的处理,运用适宜的质量风险管理工具开展偏差调查和影响性评估,识别偏差的根本原因,助力企业质量管理水平提升。

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.