美国FDA验证高级培训.pptx

美国FDA验证高级培训DenisKluba博士吴培栋博士1

目录TableOfContents验证定义CGMP对验证旳要求验证历史与期望验证综述验证主方案与规划实施验证旳措施验证旳技术内容要求执行验证方案工作流程变化控制再验证总结2

PartOne:WhatisValidation??第一部分：验证定义3

WhatisValidation?ForthisSeminaritreferstotwothings:1.TheUSAFDArequirementsthatmustbemetinordertosuccessfullyandcontinuallyselldrugproductsintheUSA2.Activitiesthatwillcontributetothesuccessofthecompanyinthemanufactureofdrugproducts验证旳含义？4

Validation“Anythingwhichyoucannotunderstandisindistinguishablefrommagic.”ArthurC.Clark“Validationmaynotbemagic!”