6.13 All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed.
——选自ICH Q7A
针对于不使用进销存软件,大家的批次全部distributed的时间点是如何进行良好的与文件管理员进行及时,准确的传递的呢????以便于文件管理员对每批批记录进行到期时间标识???