Transcription of ANDA Stability Guidance Opportunities & Challenges
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ANDA Stability Guidance Opportunities & Challenges
ANDA Stability Guidance Opportunities & Challenges Upinder S. Atwal, Team Leader OGD/CDER/FDA GPhA/FDA CMC Workshop June 3, 2014 1 Agenda Introduction Opportunities & Challenges Conclusions 2 Introduction Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers 3 Introduction contd. History of development 2011, 2012, 2013 Presentations, and in- house meetings held with stake-holders and FDA including GPhA Workshops Questions from the Industry and GPhA were collected for responses; draft Q&A Guidance was published Two webinars (DIA, and SBA) were hosted by the members of the Stability working group 4 Implementation June 20, 2014 is the implementation date The Q&A Guidance will assist in the adoption Referenced ICH Stability Guidances: Q1A(R2) Stability Testing of New Drug Substances and Products with Glossary Q1B Photo Stability Testing of New Drug Substances and Products Q1C Stability Testing of New Dosage Forms Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Products Q1E Evaluation of Stability Data 5 Opportunities Multiple API Sources A minimum of two lots of API to be used for making the primary batches Allowance for proposing two API sources at the ti
ANDA Stability Guidance Opportunities & Challenges Upinder S. Atwal, Ph.D. Team Leader . OGD/CDER/FDA . GPhA/FDA CMC Workshop . June 3, 2014 . 1
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