Method Verification

According to the USP, a method verification is an evaluation of the suitability of a compendial method under actual conditions of use. Per the USP, a method verification is required the first time a laboratory uses the compendial method for testing a specific sample.

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Method verifications are not as elaborate as method validations. They generally are performed using existing methods that are available in compendia such as USP, NFBP or EP.

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There have been clients that come to us in a rush to get their product market that have overlooked the importance of method verifications. Without proper testing, a method's veracity cannot be established. Regulatory authorities tend to frown upon lack of sufficient evidence that a laboratory can perform a test reliably with both precision and accuracy.

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For method verifications, BRS Analytical prepares a method verification protocol that outlines the testing to be performed as well as the conditions under which they will be executed. These protocols are reviewed by our clients and customized for any specialized needs.

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BRS Analytical regularly conducts a wide range of testing on a wide variety of pharmaceutical products. Our in-house experts provide guidance to our clients in selecting the most appropriate and cost-effective testing for your product.

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Generally, the following tests are part of the method verification protocol:

• System Suitability

• Method Precision

• Linearity

• Accuracy

• Limit of Detection (LOD)

• Limit of Quantitation(LOQ)

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The accuracy of test data and the level of regulatory compliance under which the data is generated is extremely important to BRS.

Please allow us to assist you in your verification testing needs.

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BRS Analytical Services adheres to the guidance in the USP General Chapter <1226> Verification of Compendial Methods.