批记录管理.pptVIP

批记录管理 - GMP 培 训 批记录管理 一、GMP要求 Batch Production and Control Records shall be prepared for each batch of drug product produced，and include complete information relating to the production and control of each batch. These records shall include:批生产及控制记录应用于每批生产的药品，包括与每批生产及控制相关的全部信息。这些记录应包括： 批记录管理 An accurate reproduction of the appropriate master products and control records, checked for accuracy, dated, and signed.产品生产及控制记录的准确再现，准确性的检查，记录日期，以及记录人的签名。 Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished including: 每批产品的生产、加工、