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目的探讨HACCP(危害分析与关键控制点)在制药行业应用的前景。方法探讨HACCP理论,并分析其在国内外应用的现状。结果 HACCP是最早应用于食品行业的一种质量风险管理工具,随着质量风险管理研究的深入,HACCP越来越多的应用到制药、航天、化工、供水、饲料等其他高风险行业。结论 HACCP是一个应用性较强、需要因地制宜和持续改进的质量风险管理工具。具有简明、实用、有效及公认的可靠性,未来它将进一步向制药、环保等行业发展,并将深入到产品管理制度中去。
Objective To explore the prospect of HACCP (Hazard Analysis and Critical Control Point) application in pharmaceutical industry. Methods The HACCP theory is discussed and its application in the world is analyzed. Results HACCP is the first quality risk management tool used in the food industry. With the further research on quality risk management, HACCP is increasingly applied to other high-risk industries such as pharmaceutical, aerospace, chemical, water supply and feed. Conclusions HACCP is a highly applicable quality risk management tool that needs to be tailored to local conditions and continuous improvement. With concise, practical, effective and recognized reliability, in the future it will further develop into the pharmaceutical and environmental protection industries, and will go deep into the product management system.