摘要
目的促进我国医疗器械生产企业验证工作科学有效的开展,提高医疗器械产品质量水平。方法以湖南省某医疗器械生产企业为实证研究对象,基于风险管理理论,运用失效模式与影响分析风险管控工具对其厂房设施进行了风险评估与风险再评价。结果通过基于风险管理的验证,确定了验证范围与程度,并采取控制措施,有效的降低了质量风险的发生,成功地满足了医疗器械生产质量管理规范(good manufacturing practice,GMP)规范要求,从基础上保证并提高了产品质量与质量安全。结论分析总结了一套适合我国现行医疗器械生产企业厂房设施的GMP验证流程,并提出了医疗器械生产企业在实施验证工作时需要关注的三个方面。
Objective To promote the scientific and effective development of the validation work of medical device manufacturers in China,and improve the quality level of medical device products.Methods Taking a medical device manufacturer in Hunan Province as the empirical research object,based on the risk management theory,the failure mode,effect analysis risk management and control tool were used to conduct risk assessment and risk reassessment on its factory facilities.Results Through the validation based on risk management,the scope and extent of validation were determined,and control measures were taken to effectively reduce the occurrence of quality risks,successfully meet the requirements of GMP specifications,and ensure to improve product quality and quality safety on the basis.Conclusion A set of GMP validation process suitable for the current plant facilities of medical device manufacturers in China is analyzed and summarized,and three aspects that medical device manufacturers need to be paid attention to when implementing validation is proposed.
作者
陈炜
申琦
梁毅
CHEN Wei;SHEN Qi;LIANG Yi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)
出处
《沈阳药科大学学报》
CAS
CSCD
2024年第11期1519-1530,共12页
Journal of Shenyang Pharmaceutical University
关键词
风险管理
验证
医疗器械
risk management
validation
medical device
作者简介
陈炜(1997-),男(汉族),重庆人,硕士研究生,E-mail:18883850965@163.com;通信作者:梁毅(1964-),男(汉族),江苏南京人,教授,博士,主要从事药品、化妆品、医疗器械质量管理与国内外药品注册的研究工作,E-mail:ly606@sohu.com。
