1、 1Validation TrainingIntroduction to Process Validation过程验证简介2Validation TrainingCourse 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 val
2、idation描述如何管理过程验证 Sterilization Validation Brief Introduction灭菌验证简介3Validation TrainingFIRST SECTION第一部分Definitions of Validation验证的定义Significance of a Validation验证的意义4Validation TrainingWhat is Validation FDA DefinitionFDA对验证的定义 Established documented evidence which provide a high degree of assuran
3、ce that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.建立提供高度保证的书面证据，确保特定过程将持续生产满足既定参数和质量属性的产品。5Validation TrainingWhat is Validation ISO Definition ISO对验证的定义 Confirmation by examination and provision of objective evidence that t
4、he particular requirements for a specific intended use are fulfilled.通过测试和提供客观证据，确认达到特定预期用途的特殊要求是否得到满足。6Validation TrainingWhat is Validation Baxters Definition百特公司对验证的定义 “Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are
5、 consistently fulfilled.”“通过测试和提供客观证据，确认达到特定预期用途的特殊要求是否得到持续满足。”7Validation Training Why do we validate?为什么我们要进行验证？1. To control the assessment and implementation of equipment and processes, which might impact product safety, quality or efficacy 为了控制那些可能影响产品安全性, 质量或功效的过程的评估和实施.2. Fulfill regulatory r
6、equirement满足法规的要求8Validation TrainingValidation Learning Curve验证学习曲线Numbers of system errors系统错误数量Begin validation开始验证Begin Production开始生产Begin Production开始生产End validation验证Savings $Without validation有验证With validation有验证Time Begin ProcessDevelopment开始过程 9Validation TrainingBenefits of Validation验证的 Quality Benefits 质量 面的 End User Benefits 用 面的 Business Benefits 面的 10Validation TrainingImprove Customer Satisfaction/ Reduce Cost提高客 满意度/ Reduce defects, scrap and rework品， 品和 Reduce complaints and field corrective actions 和 施 Reduce development time 期 Faster time to market进currency1的“
