试论风险管理在药品生产监管中的应用

Risk management in the supervision of drug production

风险管理包括风险识别、风险分析和评估、风险应对三个方面.在药品生产的风险管理中,存在管理者对风险管理的认识不足,风险管理意识欠缺,风险管理缺乏灵活性和完整性,不重视对物料供应商的风险管理等问题.要解决这些问题,需要不断强化相关人员的风险意识,加强风险培训工作,建立和完善一套科学的生产风险管理体系,并结合生产工艺的变化进行实时更新和完善.

Risk management includes identification,analysis and assessment,and response of risks.Despite shortcomings of lack of awareness,inflexibility in risk management and indifference of material suppliers,countermeasures are offered to strengthen risk management for drug producers,and promote the production technology.