Batchproductionrecords 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。
2
All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch.