Method Verification

Method Verification

The USP defines method verification as an assessment whether a Compendial method is suitable under actual conditions of use. USP requires that a method verification is conducted the first time that a laboratory employs a Compendial method for testing a specific sample type. Thus, method verification is specific to the laboratory performing the testing and to the sample type being tested.

Keeping this in mind, if a laboratory has successfully verified a specific method for a specific sample type, but a new sample type is submitted to that lab for testing, it would trigger the need to reconduct method verification for the new sample type. Applying the same logic, if a method verification has been successfully conducted by a laboratory, but the same sample type is sent to a different lab for testing but employing the same method, this too would trigger the need to conduct method verification since this would be the new lab’s first usage of the method.

Strategies for conducting Method Verification can vary greatly, depending upon the nature of the method and of the sample type. One element of Method Verification that must always be performed, however, is the determination of method specificity with regard to the sample type being tested. This is important since USP methods are typically developed and validated for only a single sample type. Specificity activities will determine if any interferences, positive or negative, exist when the method is applied to the specific sample type to be tested.

Specific details regarding method verification may be found in USP General Chapter <1226> entitled “Verification of Compendial Procedures.”

Our Capabilities

CPT^SM maintains state-of-the-art Analytical, Microbiological, Clinical, Photobiology and In Vitro Toxicology laboratories, all at a high level of regulatory compliance and at your immediate disposal for determining the quality, safety, stability and efficacy of your products.

CPT^SM regularly conducts all types of testing in our specialized departments on a wide range of products including pharmaceuticals (OTC and Rx), medical devices, dietary supplements and personal care/cosmetics. Our in-house experts offer one-on-one guidance in selecting the most appropriate and cost-effective testing strategies for your products.

Regulated products require testing of the highest accuracy, conducted within an environment of full regulatory compliance. Because the accuracy of test results and the level of compliance under which they were generated are of equal importance to our professionals at CPT^SM, just as they are to FDA and other regulatory agencies, please allow us to assist you with all of your testing needs.