Production of Multi-API products is a common scenario in every drug manufacturing site. However, we have observed variances in the approach to establish residue limits of these. Primary points of debate are around Shared Surface Area calculations and batch size. In this Micro Article, we will put these confusions to rest.
There are two cases that will be discussed in this Micro Article. Case-1: When the Multi-API Product is the previously manufactured Product Case-2: When the Multi-API Product is the subsequently manufactured Product.