GMP验证过秤胩介绍.ppt

Introduction to Process Validation 过程验证简介 Course Contents 课程内容 Explain what validation is and why we do it 验证的定义及进行验证的原因 Review what processes need to be validated 检查什么样的过程需要验证 Describe an effective process validation 描述一个有效的过程验证 Describe how to manage process validation 描述如何管理过程验证 Sterilization Validation Brief Introduction 灭菌验证简介 FIRST SECTION第一部分 Definitions of Validation 验证的定义 Significance of a Validation 验证的意义 What is Validation FDA DefinitionFDA对验证的定义 Established documented evidence which provide a high degree of assurance that a specific process will con