A numbered copy of the M-aster batch production record is produced for every batch which serves as an Operating Procedure.
每一批批生产记录根据操作程序,按主批生产记录的副本进行填写。
Review batch production record after production finished, assure production process conform to process procedure GMP requirements.
生产结束后审核批生产记录,确保生产过程符合工艺规程要求和GMP要求。
Draft out production management document batch production record, modify process procedure GMP relative record, assure production work has regulation to follow.
组织编写生产管理文件,批生产记录,修订工艺规程,及GMP相关记录,确保生产工作有法可依。
The batch production record should be checked before issuance to ensure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.
批记录发放之前,应当检查版本是否正确,是否是相应生产工艺规程的准确明了的再现。
Materials, which fail to meet the specification, are documented in an appropriate document (i. e. analytical report). The document is attached for the finished material to the batch production record.
不符合质量规格的原料以一种适当的文件(如检验报告)进行存档。这份文件附在最终产品的批生产记录中。
Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.
使用前,生产人员应当确认该物料是要生产的中间体或原料药的批记录中指定的。
Prior to use, production personnel should verify that the materials are those specified in the batch record for the intended intermediate or API.
使用前,生产人员应当确认该物料是要生产的中间体或原料药的批记录中指定的。
应用推荐