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FDA is announcing the availability of a draft guidance for industry entitled “ANDAs: Stability Testing of Drug Substances and Products.” Because of increases in numbers of ANDAs and their complexity, the FDA is considering standardizing stability testing policies by adopting recommendations in the following stability related ICH guidances: (1) “Q1A (R2) Stability Testing of New Drug Substances and Products,” November 2003; (2) “Q1B Photostability Testing of New Drug Substances and Products,” November 1996; (3) “Q1C Stability Testing for New Dosage Forms,” November 1996; (4) “Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products,” January 2003; and (5) “Q1E Evaluation of Stability Data,” June 2004. FDA is also considering adopting the ICH outlined definitions, glossaries, references, and attachments.
Although the ICH stability guidances were developed for new drug applications to ensure the stability of new drug substances and products, FDA believes the recommendations provided in the ICH guidances on stability testing are appropriate for ANDAs as well. This guidance contains FDA's recommendation that ANDAs submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), and the drug master files that support ANDAs, follow the stability recommendations provided in the ICH stability guidances.
This guidance also replaces stability study storage condition recommendations made in an August 18, 1995, letter that the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs (OGD) sent to all ANDA applicants, which is available on CDER's Web site:
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on stability testing of drug substances and products for ANDAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
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Persons with access to the Internet may obtain the document at either