Comment from Anonymous
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Summary: The commenter requests clarification in the draft guidance regarding the use of alternative compendial monographs (such as the European Pharmacopeia) for unspecified impurities and degradation products. They argue that the guidance should explicitly state that these criteria are appropriate if there are no toxicological concerns, similar to the language provided for specified impurities.
For ANDA, starting on line 249, the guidance states:
“The acceptance criteria for specified impurities in drug substances and specified degradation products in drug products in a relevant USP monograph or, if there is no USP monograph, a relevant alternative compendial monograph, are considered appropriate if there are no toxicological concerns.”
The draft guidance does not address whether acceptance criteria for unspecified impurities in drug substances and unspecified degradation products in drug products in a relevant USP monograph or, if there is no USP monograph, a relevant alternative compendial monograph are considered appropriate.
For example, we would like to use the European Pharmacopeia drug substance monograph acceptance criteria (as there are no USP monographs) for specified impurities (identified and unidentified) in the drug substance and for specified (identified and unidentified) degradation products in the drug product which would be allowed according to the draft guidance.
However, the draft guidance does not mention if this is also allowed for unspecified impurities/degradation products. Clarification needs to be added to the guidance if acceptance criteria for unspecified impurities in drug substances and unspecified degradation products in drug products in a relevant USP monograph or, if there is no USP monograph, a relevant alternative compendial monograph, are considered appropriate.