Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
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The guidance, ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers, is a follow-up to a draft guidance released in September 2012, and then finalized in June 2013.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FDA's latest Q&A guidance finalizes an earlier draft guidance by the same title released in August 2013 which clarified a bunch of specific-but nevertheless important-issues.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