FDA on changing acceptance criteria re: analytical method validation

ChemistAnalytical

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#1
Hi all. I'm curious how the FDA would view the loosening of acceptance criteria for analytical method validation.

For example, unnecessarily tight specifications were approved for a analytical method validation protocol. The validation failed some of these specifications and it was documented in the report. The FDA typically accepts acceptance criteria of 80% to 120% for this parameter, accuracy of impurities. The acceptance criteria which were not being met was 95% to 105%.

Are there any issues with loosening the specification based on the assumption that the original specifications were not appropriate?
 
#2
the reason/trigger of assumption that original specification were inappropriate, on its own could not be complete justification for relaxing the acceptance criteria.
even if its true, it leads to question the basis for approving the protocol, or even SOP , if the tighter values are traceable to it.

hence, add the details of
1. how/why this particular method does not fit the acceptance criteria,
1.1 burden would increase if the same ( analytical ) technique and material type are similar to the previous validations where the criteria is met
2. add references to the other pharmacopoeia, regulatory expectations criteria

add the product or molecule specific criteria for same.
https://www.fda.gov/media/71846/download
http://pqri.org/wp-content/uploads/2015/08/pdf/White Paper.pdf
 
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