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 497
OP 508
DO 10.5731/pdajpst.2021.012662
VO 76
IS 6
A1 Jens Lamerz
A1 Oana Mihaela Danila
A1 Andreas Schuster
A1 Janine Burren
A1 Christian Moessner
A1 Wolfgang Göhring
A1 Pankaj Rege
A1 Helmut Stahr
A1 Stefan Hildbrand
A1 Daniel Coleman
YR 2022
UL http://journal.pda.org/content/76/6/497.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. If 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 article 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.