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Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
Published in 2004, FDA’s Pharmaceutical cGMPs for the 21st Century, A Risk-Based Approach (1) provided the initial momentum needed to help promote collaborative efforts within the pharmaceutical industry. Designed to modernize pharmaceutical manufacturing and make it more efficient, the guidance highlights the importance of continuous improvement to improve efficiency by optimizing processes, reducing variability, and eliminating wasted effort.
Reducing variability benefits both patients and manufacturers; therefore, regulators have voiced strong support for continuous improvement activities. For example, FDA and the International Council for Harmonization (ICH) support quality-by-design (QbD)-based product development.
QbD, advanced in ICH Q8 (2), focuses on the use of multivariate analysis in combination with knowledge management tools to understand the impact of critical material attributes and critical process parameters on drug product quality attributes. The heightened product and process understanding that result from using this framework provides a foundation for continuous improvement.
Vol. 41, No. 8
When referring to this article, please cite it as J. Collins et al., “A Continuous Improvement Metric for Pharmaceutical Manufacturing,” Pharmaceutical Technology 41 (8) 2017.