Transcription of ANDA Stability Guidance(s)
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ANDA Stability Guidance(s)
ANDA Stability guidance (s) Radhika Rajagopalan , Quality Assessment Lead OLDP-OPQ-CDER GPhA June 2015 1 Agenda Highlights Q1D Matrixing while considering an ANDA Q1 E Other items 2 ANDA Stability guidance 3 Improve ANDA quality and eliminate differences between NDA and ANDA CMC expectations Decrease Stability related failures Follow ICH Stability Guidances Capitalize on considerable awareness Highlights Q&A guidance Companion guidance Small scale batch size defined for many dosage forms Listed exemptions for pilot scale batch size Clarified multiple lots to 2 discrete lots of API for most dosage forms Expectation for the addition of second source for API included Miscellaneous questions on Stability studies answered 4 Highlights 5 Clarify misunderstandings such that RTR can be avoided at the time of ANDA submission 2. At the time of submission, provide 6 months of data that include accelerated and long-term conditions. FDA recommend following ICH with respect to intermediate conditions to support shelf-life.
ANDA Stability Guidance(s) Radhika Rajagopalan Ph.D., Quality Assessment Lead . OLDP-OPQ-CDER . GPhA June 2015 . 1
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