FDA Releases Draft Guidance on Analytical Procedures and Methods Validation for Drug Substances, Drugs and Biologics

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FDA has just issued a draft guidance on analytical procedures and methods validation for drug substances, drugs and biologics.

The guidance complements the International Conference on Harmonisation (ICH)  guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and validating analytical methods. This revised draft guidance does not address specific method validation recommendations for biological and immunochemical assays for characterization and quality control of many drug substances and drug products.

The guidance covers the following:

  • ANALYTICAL METHODS DEVELOPMENT
  • CONTENT OF ANALYTICAL PROCEDURES
  • REFERENCE STANDARDS AND MATERIALS
  • ANALYTICAL METHOD VALIDATION FOR NDA, ANDAs, BLAs, AND DMFs
  • STATISTICAL ANALYSIS AND MODELS
  • LIFE CYCLE MANAGEMENT OF ANALYTICAL PROCEDURES (including revalidation and comparability studies
  • FDA METHODS VERIFICATION

Read the draft guidance here.

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