FDA has released answers to questions received during the public comment period for the draft guidance document Stability Testing of Drug Substances and Products, Questions and Answers, published in the Federal Register on September 25, 2012 as well as responses to comments received on the draft of this guidance published in the Federal Register on August 27, 2013. The Q&A document responds to concerns regarding drug master files (DMFs), drug product manufacturing and packaging, and stability studies.
In the Q&A document, FDA clarifies the stability testing data recommendations for abbreviated new drug applications (ANDAs). According to the Q&A document, “the stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to postapproval changes.”
FDA addresses questions related to the timing and amount of accelerated stability and long-term stability data required for an ANDA, intermediate stability study requirements, stability bracketing and matrixing, shelf-life calculation requirements, sample storage times, and more.