Abstract
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.
- acceptance limits
- characterization experiments
- critical process parameter
- critical quality attributes
- impact ratio
- impact ratio threshold
- Received June 17, 2021.
- Accepted July 1, 2022.
- Copyright © 2022, Parenteral Drug Association
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