FDA资料幻灯片.ppt

;目录Table Of Contents;Part One: What is Validation?;What is Validation?;Validation;Validation Is.....;To Consistently Produce A Desired Known Product;How Do We Validate?;First three steps to CGMP compliance;Boundaries of Validation;Validation Life Cycle Approach;Validation Life Cycle Approach;Benefits of Validation;Elements Of Contemporary Validation In The US;cGMP and ISO-9000 - Similarities;cGMP and ISO-9000 - Differences;Benefits of the Systems Approach to Validation;The Validation Program;Part Two: GMP Requirements;GMP requirements;cGMP in the Pharmaceutical Industry;Regulatory Requiremen