batch record

基本解释

All tests and results should be fully documented as part of the batch record.
所有的检测和结果应全部记录作为批记录的部分。
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Release of products entails a Batch Record and Quality Control documentation reviewed prior to release.
产品的放行需要一个批记录以及先前被审核放行的质量控制部门的文件。
If a sample is selected from a batch not described in the application, an amendment containing a copy of the batch record and certificate of analysis should be provided to the ANDA.
如果样品是来自于一申请中未提及的批次的话，则在ANDA中还应当要补充一份批记录和分析报告单的复印件。