I have a question about an AOAC Table of "Suggested Acceptance Criteria." This table was compiled by AOAC and is composed from data gathered from USP and ICH Guidelines.

This table is "Suggested Acceptance Criteria" for %Area obtained when running %Purity for materials that are 100%pure (i.e., 99.99%).

So if one runs 2 methodologies...meaning the analysis using 2 different methods: GC and an HPLC, or 2 different GCs with two different columns...or same GC with 2 different columns, etc... I am trying to understand how when doing a Validation that a lab can adjust this "Suggested Criteria" to meet the conditions in a specific laboratory setting.

So let's say this is a GC analysis. Lets say I have 2 systems and I have 2 columns with slightly different chemistry and I am analyzing MeOH, IPA, or EOEMA that is 99.99% pure.

This criteria for 100% Purity materials is extremely tight and calls for 0.5% difference when comparing results from two methodologies on "SAME DETECTOR" meaning same system. It calls for 1.0% difference when comparing two different methodologies on the same detector, meaning same instrument or system.

On what basis can this margin be expanded? I am not sure this is within the power of the validation group. Is there a guideline somewhere that explains how "Suggested Criteria" can be changed . Also, changing suggested criteria has to be justified. It has been suggested that these margins can be widened based on the fact that the accepted criteria for System Suitability in this particular environment is </+ 2.0%.

I am not convinced that this singular value for system suit acceptance of </= 2.0% is enough of a statistical result to widen those margins.

Where can I go to look up literature that is going to explain how these "Suggested Criteria" can be adjusted for a particular lab and a particular analysis.

This refers to %AREA obtained

So if 2 analyses are run on different columns with different GC systems, or 2 analyses are run on different columns on the same system and each analysis passes all established criteria as outlined...but then when both methods on both systems or both methods on the same system are compared using this "Suggested Acceptance Criteria" of 0.5% for different columns on same system and then 1.0% for different columns on different systems they do not pass within this "Suggested Acceptance Criteria." Since it is "Suggested Acceptance Criteria" there must be a way of justifying widening those percentages. So how can that be accomplished???

I am not sure, but I may have answered my own question. So if we have all this data that points to all individual analyses run as meeting all established criteria. Then maybe the way to justify widening this particular %Area criteria is to compile all the results for all analyses and use that to generate a new "Acceptance Criteria."

I am trying to understand how a laboratory can widen this margin and who has the power to widen this criteria. I hope this question was phrased clearly.