Method verification is the process of confirming that an existing method is suitable for a given product or matrix. If the standard method changes, the confirmation or verification should be repeated. Method verification is vital when:
- Transferring an already validated method
- The matrix being tested is not one that was used or cited in the literature method
- Confirming a specific method can be successfully carried out a laboratory or site
- Demonstrating a method is performing reliably, accurately, and precisely for its intended application
When is Method Verification Appropriate?
Method verification is typically performed:
- For compendial methods and FDA monographs
- To support submissions for certification
- To confirm product quality after exposure to questionable shipping and/or storage conditions
Wellness and supplement product manufacturers are increasingly relying on method verification to ensure product quality and safety, as well as to support submission to certification bodies.
Is Method Verification Necessary?
Method verification delivers more than just peace-of-mind. Method verification confirms that the method is not only appropriate for a specific sample matrix, but also that the method is reproducible and effective. If a manufacturer experiences an adverse event, verified test methods instill confidence in data and subsequent investigation results.
For example, if the method used to test a finished product for potency was not first verified, the manufacturer of the product in question would have difficulty establishing that the data generated accurately represents the quality of the finished product.
Choosing the Right Contract Lab for Method Verification
As a partner, your contract laboratory should have the industry and scientific expertise to determine when method verification is both appropriate and necessary. Furthermore, the right contract lab will have experience and familiarity with method verification. Do you have a specific project in mind? Get in touch with us or speak with a regulatory expert.
Looking for more information on method development and method validation? Our Analytical Methodology for CMC Whitepaper provides valuable insight into the importance of robust test methods for CMC dossiers.
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