A review of 483's and Warning Letters issued by the FDA, shows ongoing enforcement for USP method verification. Since the issuance of USP <1226>, the FDA has interpreted the term “under actual conditions of use” to be specific to each sample matrix. All USP compendial methods must have verification performed to demonstrate competency in running the method. In other words, you are mandated to prove you can successfully preform the USP method, similarly as you would in a method transfer. If USP tests are outsourced, you should have the CRO perform verification on your specific matrix.
Stay posted! More information on the FDA and USP <1226> will be available on our website soon.