Wednesday, October 3, 2012

FDA - ANDA Stability Testing - New Draft Guidance Document

The FDA just released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH).

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products
 or
Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products (PDF Version)

The following existing ICH guidances address stability for new drug substances and products, and are referred to in the FDA guidance:

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 

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