GDP良好文件规范.pptVIP

Good Documentation Practices;良好的文件处理规范（GDP）;Objectives;目的; Documentation is the key to a successful GMP/QSR audit. Documentation should be complete, accurate, legible and organized. “If it is not written down, it didn’t happen.”  -the FDA When entries are made in a clear readable manner, it demonstrates to an auditor that the personnel who have completed the task have quality consciousness that will help ensure a safe and effective product.;为什么要实行GDP？;Why GDP?;为什么要实行GDP？;Original Data;原始数据;Original Data (cont.);原始数据（续）;Data types;数据类型;Signatures ;签名;Recorder Responsibilities;记录员职责;Reco