FDA - ANDA Stability Testing - New Draft Guidance Document

• FDA cGMP online training classes, courses, and programs offered by SkillsPlus International Inc.

Updated October 31, 2022:

The FDA just released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the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

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 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website