Comment from Pfizer
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Summary: The commenter suggests specific language revisions to the draft guidance to clarify that identification thresholds can be consistent with ICH Q3A(R2) and ICH Q3B(R2) standards. They provide specific text examples to ensure the guidance allows for these established limits or other justified limits.
Clarify that the identification thresholds may be consistent with those in ICH Q3A(R2) and ICH Q3B(R2) or an otherwise justified limit. For example, proposed text:
Line 135-136: “Any unspecified degradation product with an acceptance criterion that does not exceed (i.e., ≤) the identification threshold defined in ICH Q3B(R2) or otherwise justified limit.”
Line 146-147: “Any unspecified impurity with an acceptance criterion that does not exceed (i.e., ≤) the identification threshold defined in ICH Q3A(R2) or otherwise justified limit.”