If the drug product (DP) testing scheme is intended for the European market and only Ph. Eur. chapters have been verified, and you wish to apply it to the U.S. market, you must check whether the test is harmonized between the Ph. Eur. and the USP.

For non-harmonized tests, it is necessary to validate the method according to USP requirements. You may continue using the same method from the Ph. Eur., but you must demonstrate that it meets USP analytical performance characteristics (e.g., accuracy, precision). If you decide to adopt the USP method, method verification is required.

Verification does not require full validation but does require evidence that the method performs as intended under your laboratory conditions. Refer to USP General Chapters <1225> (Validation) and <1226> (Verification) for detailed guidance.

Join Dr. Patanachai “Kong” Limpikirati from Chulalongkorn University to learn more about the basic regulatory science underlying drug substance and drug product specifications of monoclonal antibodies.

Watch the On-Demand presentation now: https://bio-qc.com/the-basic-regulatory-science-behind-drug-substance-and-drug-product-specifications-of-monoclonal-antibodies-and-other-protein-therapeutics/

Plus, don’t miss his expert insights during the panel discussion on Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in accordance with ICH Q6B.