Q &A | Must the Production Batch Be the Same As the Sterilization Batch, and Who Shall Pevail?

Q: The specification stipulates that batch number management regulations should be established to clarify the relationship between the production batch number and the sterilization batch number. Does the production batch and the sterilization batch must be consistent?

A:A batch number is a unique combination of numbers and/or letters used to identify a particular batch. A production batch refers to a product with the same nature and quality that is continuously produced under the same process conditions over a period of time. A sterilization batch refers to products with the same sterility assurance level that are sterilized under the same process conditions in the same sterilization container. Enterprises can determine the relationship between the production batch and sterilization batch of the same product. If the production batch is too large to be sterilized at one time, it can be split into several suitable sterilization batches; on the contrary, if the production batch is small, it can be sterilized by several production batches together and constitute the same sterilization batch.Translated with www.DeepL.com/Translator (free version). However, it should be noted that when the sterilization batch consists of several production batches, the factory inspection should still be carried out according to the production batch.

Source:NMPA