ICH Q7a规定如下:
6.51 These records should be numbered with a unique batch or identification number, dated and signed when issued. In continuous production, the production code together with
the date and time can serve as the unique identifier until the final number is allocated.
6.51 批记录在发放时应当有一个唯一的批号或标识号,有日期和签名。连续生产时,在最终批号确定前,可以将产品代码、日期和时间结合起来作为唯一的识别符。