Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

by Mark F. Witcher
Volume 15, Issue 4 (Winter 2016/2017)

This paper, the second in a three-part series on ICH Q9 quality risk management (QRM), uses a process-based risk structure to identify product quality risks from variability in input parameters and process behavior. This paper outlines a method to identify the three types of input parameters and how they can be placed into an ICH Q8 defined design space structured to clearly categorize and control the input parameters such that they can be evaluated for their impact on product critical quality attributes (CQAs). Based on their placement in the well-structured design space, the parameters are rated using a risk severity and uncertainty index to calculate a risk rating for review and acceptance. The process-based risk structure can also be used to mitigate the likelihood of the risk consequence by modifying the processes to manage the uncertainty of the input parameters and control the process’s behavior...

Witcher MF. Quality risk management (QRM): part II – evaluating the impact of process parameters on critical quality attributes for biopharmaceutical products. BioProcess J, 2017; 15(4): 22–31. https://doi.org/10.12665/J154.Witcher.Q.

Posted online February 15, 2017.