batch record

基本解釋

All tests and results should be fully documented as part of the batch record.
所有的檢測和結果應全部記錄作為批記錄的部分。
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Release of products entails a Batch Record and Quality Control documentation reviewed prior to release.
產品的放行需要一個批記錄以及先前被審核放行的質量控制部門的文件。
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.
如果樣品是來自于一申請中未提及的批次的話，則在ANDA中還應當要補充一份批記錄和分析報告單的復印件。