记录一个批号的产品制造过程中使用原辅材料与所进行操作 的文件，包括制造过程中控制的细节。简称BPR（ Batch Process Record）。
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。
A numbered copy of the M-aster batch production record is produced for every batch which serves as an Operating Procedure.
确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门；
To ensurethat the batch records of processing and packaging are evaluated and signed bya designated person before they are sent to the quality management department;
应当为每种中间体和原料药准备批生产记录，内容应当包括与各批生产和控制有关的完整资料。
Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch.
应用推荐