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(jié)果應(yīng)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(chǎn)品的放行需要一個批記錄以及先前被審核放行的質(zhì)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(yīng)當要補充一份批記錄和分析報告單的復(fù)印件。