How much bridging is required? How long does it take to submit an alternative method?
Generally, I think it is essential to distinguish a method bridging from an instrument change. For method bridging (moving from one analytical method to another), I would refer to Francisca's talk and her expertise on the extent of data generation and evaluation required.
For instrument changes, it depends on the degree of comparability between the readouts of both instruments: If their performance is comparable, ICHQ2R2 chapter 2.2 allows for a science-based update (no re-validation efforts required). If they do not perform comparably, a partial or full re-validation may be required. We describe this procedure in more detail in https://doi.org/10.1002/elps.70004 , especially check out figure 2 and chapter 4.1.
Regarding the time requirement for submission: In case of an instrument change, I believe it highly depends on whether the original method submission describes the old instrument as the unique instrumentation to be used or as an example, allowing for equivalent alternatives.
In case of an alternative analytical method, I think it depends on many factors, such as the local setup of analytical target profiles, the submission landscape... What is generally good is that with ICH Q14, authorities as well as companies recognised the need for efficient procedures regarding updates.
Join Dr. Anne Ries from Boehringer Ingelheim Pharma to explore Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics.
Watch the On-Demand presentation now: https://bio-qc.com/best-practices-for-updating-analytical-procedures-in-drug-development-and-manufacturing/
Plus, don’t miss her and Dr Francisca Galindo Garre's expert insights during the panel discussion on Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing.
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