FDA Guidance on analytical procedures and methods validation published

The Guidance for Industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics" was published by FDA on 27 July 2015. It replaces the draft document which appeared in February 2014.

Apart from editorial amendmends the current guidance differs from the previous version mainly with respect to the following aspects:

  • A risk based approach on the need for revalidation of existing analytical methods is encouraged when changes in the manufacturing process occur during the product's lifecycle. Likewise applicants are required to periodically evaluate the appropriateness of a product's analytical methods in case of new information e.g. regarding the product CQAs or the impurity profile. New or alternative analytical methods based on risk assessments should then be considered.
  • Appropriate statistical methods should be selected among the variety of statistical techniques and appropriate literature should be consulted for information on statistical procedures when
    - developing new test methods
    - evaluating existing test methods
    - evaluating measurement system performance
    - interpreting or treating of analytical data like determining equivalence of two test methods.
    Important: the data analysis should be assured either by using appropriately validated software or independent verification for correctness.

Moreover chapter X. "References" has been updated by including revised gudelines, newly edited articles and three ASTM Standard Guides.

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