New
Micro Article of the month A Risk-Based Approach To Reduce Sampling by 50%. Read Now >
DOWNLOAD MICRO ARTICLE

How to Calculate
Residue Limits
for Multi-API Products

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.
Cleaning Validation Software
Download Micro Article
Thank you! You'll receive an email from us shortly.
Oops! Something went wrong while submitting the form.