... 批生产过程 batch-process 批生产记录 production batch records 批生产型的 operational configured ...
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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.
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。
All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch.
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。
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