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The Importance of Method Verification

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:

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.

Additional Resources

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.

 

 

Our featured blogger is Katie Morgan, Avomeen’s Senior Director of Marketing and Business Development. She has over a decade of experience establishing and implementing client development strategies, and her broad range of experience includes strategic contract development and marketing and content development.

Learn more about Katie’s expertise and experience.