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20 May 2014

FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Q&A

The FDA has published “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers” in May 2014.  This guidance contains questions and answers from public comments generated during the drafting of “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products” the final document being published in June 2013 for generics. The guideline recommends that ANDAs, and DMFs (Drug Master Files) which support ANDAs, follow ICH stability guidelines Q1A(R2), Q1B, Q1C, Q1D, Q1E. The implementation date of the Q&A is June 20, 2014.


The Q&A covers five topic areas and is intended to clarify stability testing data recommendations for abbreviated new drug applications (ANDAs) found in the short guideline.

◾ The General section mainly addressing timing, amount of data, and number of lots to use for stability studies
◾ The Drug Master File  section covers the impact of guideline to DMFs
◾ The Drug Product Manufacturing and Packaging section takes up most of the Q&A and touches on inclusion of secondary packaging in stability studies, batch size and batch definitions, definition of small scale for various dosage forms as well as “small scale” development guidance.
◾ The section on Amendments to Pending ANDA Application states amendments will be held to the standards in place of original submission.
◾ The Stability Studies section includes guidance on the technical aspects of stability studies such as time points, storage, containers and testing.


To view the Guideline Q&A, click here

To view the original Guidance, click here

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