FDA Guidance for Industry

ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers

May 2014

This guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products2 (FDA stability guidance) that published in the Federal Register of September 25, 2012.

The final guidance for industry of the same title published in the Federal Register of June 20, 2013. Comments received on the draft of this guidance published in the Federal Register of August 27, 2013 have also been incorporated. General issues; drug master files (DMFs); drug product manufacturing and packaging; and stability studies are discussed in this guidance and are intended to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs).

In this document, the terms drug substance and active pharmaceutical ingredient (API) are used interchangeably. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Download “ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers” UCM366082.pdf – Downloaded 263 times – 124 KB

ANDAs: Stability Testing of  Drug Substances and Products

June 2013

This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in the International Conference on Harmonisation (ICH) stability guidances. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. 

Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 

Download FDA Guidance in PDF

Download “ANDAs Stability Testing of Drug Substances and Products” ucm320590.pdf – Downloaded 267 times – 30 KB

Last Updated: 2016-02-08

Questions and Answers for ANDAs Stability Testing
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