A certificate of analysis is issued for every batch produced.
每批次的产品都有质量分析证书。
The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience.
起始物料的生产商/供应商检验报告应有负责人签名,其应具备适当的资质和经验。
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。
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