《美国FDA验证高级培训资料》.ppt

美国FDA验证高级培训 Denis Kluba 博士 吴培栋 博士 目录Table Of Contents 验证定义 CGMP对验证的要求 验证历史与期望 验证综述 验证主方案与规划 实施验证的方法 验证的技术内容要求 执行验证方案 工作流程 改变控制 再验证 总结 Part One: What is Validation? What is Validation? For this Seminar it refers to two things: 1. The USA FDA requirements that must be met in order to successfully and continually sell drug products in the USA 2. Activities that will contribute to the success of the company in the manufacture of drug products Validation Validation Is..... Why Do We Validate? To Consistently Produce A Desired Known Product How Do We Validate? Details Will Follow But This is the General Model First three steps to CGMP compliance document document document Boundaries of Validation Validation Life Cycle Approach Validation Life Cycle Approach Benefits of Validation Increased Throughput Reduction In Rejections and Reworks Reduction In Utility Costs Avoidance Of Capital Expenditures Fewer Complaints About Process Related Failures Reduced Testing – In-process and Finished Goods More Rapid / Accurate Investigations Into Process Upsets More Rapid and Reliable Startup Of New Equipment Easier Scale-up From Development Work Easier Maintenance Of The Equipment Improved Employee Awareness Of Processes More Rapid Automation Elements Of Contemporary Validation In The US Equipment Calibration - Process and Validation Equipment Equipment Qualification - Installation and Operational Process Development Process Documentation Performance Qualification - Validation Maintenance of Validation - Process and Equipment Change Control cGMP and ISO-9000 - Similarities Aimed at Quality Require Documentation Require Specific Quality Program QA and QC Included cGMP and ISO-9000 - Differences cGMP Aimed at Product ISO-9000 Includes Design and Service, as well cGMP Covers Activities Directly Related to Manufacturing ISO-9000 Covers Broader Range of Activities (e.g.. Purchasing) cGMP Requires Formal Validation ISO-9000 Requires Applicable Statistical Methods Benefits