New FDA Stability Storage Guidelines

FDA LogoThe FDA have issued a New Stability Guidance document earlier this month for ANDAs which now requires stability data on three batches to be generated as opposed to one batch which was the case up to now.

Over the past few years, the Office of Generic Drugs (OGD) has received numerous inquiries about what stability data FDA expects in ANDA submissions. Currently, the only published direction from OGD is contained in a 1995 letter to industry which states that OGD will accept ICH recommended long-term room temperature conditions for stability studies (i.e., 25±2°C, 60±5% RH).

Although adequate in the context of other guidance existing at that time, this recommendation is no longer sufficient to serve as a basis for stability testing for ANDAs. The following existing ICH guidances address stability for new drug substances and products:

  1. Q1A (R2) Stability Testing of New Drug Substances and Products

  2. Q1B Photostability Testing of New Drug Substances and Products

  3. Q1C Stability Testing for New Dosage Forms.

  4. Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.

  5. Q1E Evaluation of Stability Data

  6. Q1F Stability Data Package for zone III and IV

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