Method Validation Support

Method validation is the process of ensuring that a laboratory test method is accurate, reliable, and consistent in its results. It involves evaluating the performance of a method against established criteria, such as precision, accuracy, specificity, and robustness. Method validation is critical in various industries, including pharmaceuticals, food and beverages, and environmental testing. 

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Our Method Validation Services

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Contact us to learn more about our method validation services and how we can support your laboratory’s testing needs. Our team of experts is ready to assist you in ensuring the accuracy and reliability of your test results. 

With over 18 years of experience and a proven track record of helping more than 2,000 brands achieve regulatory approval, GRAS experts are here to provide the precise support you need. We guide you through every step of the testing process, helping you secure final approval and achieve your business growth goals. 

If you have any questions or need more information, please fill out the form below and submit. 

Frequently Asked Questions

While all three regulatory bodies require method validation, the criteria vary slightly: 

  • FDA emphasizes compliance with 21 CFR 211.165 for pharmaceuticals and biologics. 
  • Health Canada focuses on method validation requirements outlined in C.02.015 for pharmaceuticals and food additives. 
  • EFSA assesses validation as part of ingredient safety and novel food applications. 

Understanding these differences ensures that validation aligns with each agency’s specific standards. 

Yes, method validation is essential for the GRAS certification process. It ensures that the analytical methods used to assess ingredient safety are precise and reproducible, providing reliable data to demonstrate compliance with FDA standards. This supports the overall safety evaluation required for GRAS approval. 

Method validation ensures that all analytical methods used in testing are robust and reliable. During food safety audits, this validated data provides evidence of compliance with safety standards and ensures the consistency of results, reducing the risk of non-compliance findings. 

Compliance with ISO/IEC 17025 ensures laboratories meet international standards for test accuracy and reliability. This enhances method validation by confirming that validated methods are consistent and reproducible, critical for passing food safety audits and meeting global regulatory expectations. 

Testing food additives and preservatives requires precise methods to evaluate safety, stability, and compliance with regulatory standards. Method validation ensures these tests produce consistent, reliable results, which are essential for approval by EFSA, FDA, or Health Canada. 

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