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Posted 14 May 2014 | By Alexander Gaffney, RAC,
A new guidance document released by the US Food and Drug Administration (FDA) aims to answer some common questions regarding stability testing used to support generic drug applications.
The guidance, ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers, is a follow-up to a draft guidance released in September 2012, and then finalized in June 2013.
The stability studies are intended to ensure that a product maintains its potency, purity and overall integrity over time, such as the time it spends on a shelf awaiting use.
Under the latest guidance, FDA said it would look to standards set by the International Conference on Harmonisation (ICH), a group which counts the US, EU and Japan among its core membership.
Those guidelines are:
While those standards were developed with innovative-not generic-pharmaceuticals in mind, FDA said they are nevertheless applicable to products approved under an abbreviated new drug application (ANDA).
FDA's guidance lists seven recommendations on following the ICH standards:
But let's say FDA's guidance left you a bit confused and wanting more information. As it so happens, you're in luck.
FDA's latest Q&A guidance finalizes an earlier draft guidance by the same title released in August 2013 which clarified a bunch of specific-but nevertheless important-issues.
Some selected questions and answers are below:
ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers (FR)
Tags: Stability, Q&A, Generic, ANDA, Latest News, pharmaceutical, guidance, drug
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