RT Journal Article
SR Electronic
T1 An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2021.012662
DO 10.5731/pdajpst.2021.012662
A1 Lamerz, Jens
A1 Danila, Oana Mihaela
A1 Schuster, Andreas
A1 Burren, Janine
A1 Moessner, Christian
A1 Göhring, Wolfgang
A1 Rege, Pankaj
A1 Stahr, Helmut
A1 Hildbrand, Stefan
A1 Coleman, Daniel
YR 2022
UL http://journal.pda.org/content/early/2022/07/15/pdajpst.2021.012662.abstract
AB The identification of critical process parameters in biologics and small molecule process development is a key element of Quality by Design. The objectivity and consistency of procedures to identify critical process parameters can be improved with the use of impact ratios. Impact ratios quantify a process parameter′s practical effect on a critical quality attribute relative to the critical quality attribute′s acceptance limits. When the impact ratio is large, i.e., exceeds a predefined impact ratio threshold, the recommendation is to classify the process parameter as a critical process parameter. This paper introduces an improved and mathematically well-defined impact ratio. Benefits of this impact ratio are a consistent interpretation for many scenarios commonly encountered in practice, high suitability to automation and the possibility of standardizing on a single impact ratio definition for pharmaceutical manufacturing.