制药验证管理.pptVIP

* There are different types of documents related to validation: Master plans, protocols, reports and SOPs. Each manufacturer should have a validation master plan (VMP). It describes the overall philosophy, intention and approach to establishing performance adequacy (validation policy). It also identifies which items are subject to qualification and validation and the nature and extent of such validation. It defines the applicable validation and qualification protocols and procedures. During the inspection, you should evaluate the VMP to assess whether it covers the overall policy that defi