WHO关于批号编制系统的规定

beiwei5du

下文选自WHO GMP
15.38  There should be an SOP describing the details of the batch (lot) numbering system, with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.
15.39  The SOPs for batch numbering that are applied to the processing stage and to the respective packaging stage should be related to each other.
(这条如何理解？？是不是说如果bulk finished product生产阶段的批号:170801,那么在分包装阶段（比如多次包装）的批号比如应该设置成170801-1，-2，-3....??,而不能设置成170804，1708005等不能清晰判断关联的情况？？？）
15.40  The SOP for batch numbering should ensure that the same batch numbers will not be used repeatedly; this applies also to reprocessing.
15.41  Batch-number allocation should be immediately recorded, e.g. in a logbook. The record should include at least the date of allocation, product identity and size of batch.
（这条说道批号分发登记表，至少包括分发日期，产品以及产品生产批量，不知道大家实际上是否有实施呢？？）

独钓寒江雪丶

1、如果说要相互关联的话，我认为批号应当用170801-1、170801-2；
2、我们的产品批号和生产日期相关联，而且通过产品台账可以满足上述要求，故没有完全按照它这条实施