FDA: Draft Guidance to Validation of Analytical Methods

The FDA has published Draft guidance for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics, which supersedes the 2000 draft guidance and will also replace the 1987 FDA Guidance on Submitting Samples and Analytical Data for Method Validation.

The revised draft guidance complements International Conference on Harmonization (ICH) Q2 (R1) Validation of Analytical Procedures: Text and Methodology. The guidance is provides recommendations on how an applicant can submit analytical procedures and methods validation data and applies to:

New drug applications (NDAs)
•  Abbreviated new drug applications (ANDAs)
•  Biologics license applications (BLAs)
The draft guidance also covers the principles for drug substances and drug products covered in Type II drug master files (DMFs) but do not include investigational new drug application methods validation (INDs).

According to the draft guidance, INDs require sufficient information at each phase of an investigation to ensure proper identity, quality, purity, strength, and/or potency. The amount of information on analytical procedures and methods validation will vary with the phase of the investigation. The revised analytical validation draft guidance does not include specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products. Some bioassays, for example, are based on animal challenge models, and immunogenicity assessments or other immunoassays have unique features that should be considered during development and validation. In addition, the need for revalidation of existing analytical methods may need to be considered when the manufacturing process changes during the product’s lifecycle.