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。
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.
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.
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。
Draft out production management document batch production record, modify process procedure GMP relative record, assure production work has regulation to follow.
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.
生产过程中所用的取样方法，必须不影响洁净区的保护，当审核最终产品放行的批记录时，也要考虑环境监控的结果。
Sampling methods used in operation should not interfere with zone protection. Results from monitoring should be considered when reviewing batch documentation for finished product release.
所有生产、控制、销售记录都应保留至该批的有效期后至少一年。
All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch.
遵守日常运作的规程，准确、精确、及时地填写批生产纪录和其他的技术文件要求的文件与记录。
Follow the procedures in daily operation and document and record all information required by the batch sheet and other technical documents correctly, accurately and timely.
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.
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。
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.
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;
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;
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