Highlights From FDA's Analytical Test Method Validation Guidance

The FDA has recently updated its guidance on analytical test method validation to reflect changes in the ICH Q2(R2) guidelines. The updated guidance aims to streamline traditional validation requirements, provide flexibility for new types of multivariate and non-linear analytical test methods, and focus on critical validation parameters that ensure method reliability during routine use.

While the expectation remains for a thoroughly developed and suitable test method, the guidance introduces several changes. These include a refocusing on critical validation parameters such as specificity/selectivity, range, and accuracy/precision. Robustness and sample/reagent stability are now emphasized during method development and demonstrated on a case-by-case basis. Stability-indicating properties are demonstrated through analysis of degraded samples and stress studies. The reportable range of the test method is defined as encompassing the upper and lower end of specification limits. Analytical test method transfer now requires partial or full revalidation at the receiving site, with co-validation still an option.

The guidance also allows for the validation of multivariate analytical procedures, using calibration data to create a calibration model and validating the model with independent samples. Leanr more about the recent changes and revised guidance by reading the full article below.