By: Pauline L McGregor Ph.D CChem MRSC
Original blog posted in PMcG Consulting Blog Page
This topic is gaining momentum in the industry with the pending revisions to ICHQ2 and new chapter ICHQ14 targeted for public comment later this year.
When applied properly, the enhanced approach to analytical procedures results in improved performance throughout the life of its use. However, as with anything worth having, it comes with a price tag.
The cost is investing more time during development or prior to transferring or verifying your analytical procedures. In addition, as an analyst, you need to train yourself to think differently.
Unfortunately, I have seen too many cases where people try to “force fit” the new concepts of the enhanced approach into the “old” way of thinking. In other words, they still tackle validation from a compliance check box perspective rather than investing the time to understand the science. This often results in a “hybrid” approach that does not embrace the true value the enhanced approach has to offer hence the performance of the procedures do not improve.
One of the main differences is to consider the performance of the procedure in terms of the quality of the data it produces.
You set the required data quality in an ATP suitable for the intended purpose of your procedure and then develop a control strategy to achieve this output. Once finalized, the ATP acts as a baseline for the procedure to be measured against in terms of output throughout its life cycle.
Three stages are then applied:
1) Development and understanding
2) Qualification
3) Ongoing monitoring for acceptable performance
Application of the enhanced approach requires a change in the way we think about analytical procedures. The mind set changes to developing a control strategy with the intent to produce the required quality of the data rather than focusing on the validation performance characteristics described in the current version of ICH Q2.
This ensures you only invest time in value-added experiments. In my opinion the initial price tag is far less than what it would cost today to investigate and fix problems with “validated” procedures.
Learn how to navigate and apply the enhanced approach for your analytical procedures. Click Here for more details.