Last week, I had the opportunity to attend the BioProcess International Conference in Providence, RI. Many of the sessions I attended highlighted the advancement of the Bio-Pharmaceutical industry in applying the principles of Quality by Design (QbD).Ali Afnan, continually pushing the industry forward on this topic, led a symposia that challenged the BioPharma industry to look towards even further advancement bridging the still large gap between Quality by Design (QbD) and true process control. (Dr. Afnan had a related message at this week’s Emerson Global Users Exchange in San Antonio – Paul Thomas has posted video of that discussion on PharmaQbD.com in his article: Ali Afnan on Changing the Way Pharma Thinks.)
The implementation of QbD, with the application of Design of Experiments (DoE) and Risk Assessment, has certainly improved the ability of pharmaceutical process R&D to better understand and map out the process design space. There is no downplaying the value this can play in improving the overall process design to provide a higher probability of drug product that consistently meets efficacy and safety targets (i.e. fit for intended use). Yet, no matter how well we understand the “material attributes critical to product quality” (CQAs) and the process parameters that impact those material attributes (CPPs), there is always an inherent level of variability in the universe that does not exempt chemical and pharmaceutical processes. No matter how well a process is designed, there will always exist the possibility of batch failure.
In fact, there is actually an inherent probability of batch failure. The application of QbD helps to reduce the probability of batch failure, but it does not eliminate it. QA/QC will continue to be critical for identifying the occurrence of batch failure.*
It is difficult, in my opinion, to see how we can take full advantage of the Quality by Design efforts and minimize the probability of batch failure without applying the improved QbD process knowledge towards real-time monitoring and control of the critical quality attributes. It is this tie-in between comprehensive QbD and the application of Process Analytical Technologies (PAT) for manufacturing monitoring and control that will truly enable ongoing process validation and potentially real-time release.
*Realistically, who would ever expect to eliminate the need for QA/QC testing… but we could certainly address Quality Assurance more effectively through real-time process monitoring and control, with Quality Control testing used as a final check of product quality.
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