Comment from Pfizer
AnonymousSupportIndividual
Summary: The commenter suggests that the draft guidance should incorporate process and product knowledge when establishing acceptance criteria for total impurities or degradation products. They provide specific line references and proposed language to ensure these factors are considered alongside individual impurity criteria.
The acceptance criteria for total impurities in drug substances or total degradation products in drug products should consider process and product knowledge in addition to the sum of the acceptance criteria for individual impurities. This impacts lines 232-235, 279-282 and 314-317. Proposed text that could be used: “The acceptance criteria for total impurities in drug substances or total degradation products in drug products should consider the acceptance criteria for individual specified (identified and unidentified) and unspecified impurities in drug substances or degradation products in drug products and process and product knowledge.”