학술논문
失效模式和影响分析在原料药工艺开发中的应用 / Application of Failure Mode and Impact Analysis in APIs process development
Document Type
Academic Journal
Source
化工生产与技术 / Chemical Production and Technology. 30(1):39-46
Subject
Language
Chinese
ISSN
1006-6829
Abstract
以安徽省阜阳市临泉县某药厂的原料药A的工艺为例,探索将FMEA工具应用到原料药A工艺开发,通过组织风险管理活动、风险评估、风险分析和评价、风险控制和风险回顾,将潜在的隐性风险化解,实现产品质量风险和安全隐患的排查和消除,提高工艺稳健性和产品安全性.该方法可为化工制药行业各领域产品开发安全管理提供依据.
Taking the process of API A of a pharmaceutical factory in Linquan County,Fuyang City,Anhui Province as an example,this study explores the application of FMEA tools in the processe development of API A.By organizing risk management activities,risk assessment,risk analysis and evaluation,risk control and risk review,potential hidden risks are resolved,and product quality risks and safety hazards are identified and eliminated,which improve the process robustness and product safety.This method can provide a basis for product development and safety management in various fields of the pharmaceutical industry.
Taking the process of API A of a pharmaceutical factory in Linquan County,Fuyang City,Anhui Province as an example,this study explores the application of FMEA tools in the processe development of API A.By organizing risk management activities,risk assessment,risk analysis and evaluation,risk control and risk review,potential hidden risks are resolved,and product quality risks and safety hazards are identified and eliminated,which improve the process robustness and product safety.This method can provide a basis for product development and safety management in various fields of the pharmaceutical industry.