BIO Submits Comments on Draft Analytical Procedures and Methods Validation Guidance

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the &ldquo;Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics.&rdquo;</p>

BIO commends FDA for releasing this revision of the 2000 Draft Guidance for Industry entitled “Analytical Procedures and Methods Validation” with its strong focus on regulatory science and modernization. We note that the emphasis on the use of risk-based decisions is consistent with recent international harmonization efforts, especially with International Conference on Harmonisation (ICH) guidelines Q8, Q9, Q10, and Q11. One additional area where quality risk management can be applied is in platform-based manufacturing and testing. Manufacturers that have several products of the same type often use similar manufacturing and analytical methods. We believe that additional guidance around the use of analytical development and validation data from a similar product to support the approval of a new application would be helpful to Sponsors.