Analytical Procedures and Methods Validation for Drugs and Biologics

PDA recognizes and appreciates that FDA has incorporated many elements of PDA Technical Report 57 "Analytical Method Validation and Transfer for Biotechnology Products" in this draft guidance, including the concepts for method comparability, the concepts for "pre-determined and justified", and the approach to significant digits. PDA also recognizes the alignment with other existing standards such as USP <1224> and applauds the agency for moving towards greater harmonization. PDA's attached comments are focused on additional clarification that we believe will strengthen the document such as: when and how to apply the concepts of equivalence, non-inferiority, or superiority in comparison models; a clear statement of FDA's intention to treat analytical methods previously approved in a marketing authorization (i.e. NDA, BLA, ANDA) in a similar manner to compendial methods when evaluating new and post approval change submissions; and inclusion of methods from pharmacopeia, other than USP, which are recognized by FDA (e.g. JP, EP) per MAPP 5310.7.