Over the last few months of 2024, we saw a significant increase in the U.S. FDA asking our customers for product-specific reports proving that their products were tested on validated analytical test methods. These requests include both official compendial methods such as USP monographs and in-house methods developed by Certified Laboratories or our customers.
While regulations on this point have not changed, the FDA inspectors’ approach to checking this documentation during routine inspection has clearly changed. This was reinforced during our routine inspection at our Burbank, California laboratory in January 2025, where the inspector spent considerable time focusing on the verification of USP monographs.
Method Validation and Product-Specific Verification Now Required for OTC
Therefore, as part of our continuous improvement initiative and our mission to provide the highest standards of service to all our customers, Certified Laboratories now requires the completion of method validation and product-specific method verification to be performed on all prescription or over-the-counter (OTC) finished good products prior to the start of routine testing.
These validation/verification events will be performed to comply with the FDA guidance document “Analytical Procedures and Methods Validation for Drugs and Biologics”, and the ICH harmonised guideline “Validation of Analytical Procedure Q2(R2)”.
Furthermore, all compendial methods such as USP monographs are required to be verified prior to use on raw materials destined for prescription or OTC products in line with the process set out in USP General Chapter <1226> “Verification of Compendial Procedures”.
If you think this affects your products or you want more information, please contact your Certified Laboratories Sales or Business Development team member, who can provide more information or connect you to our dedicated Innovation and Validation team experts.