How to Prepare for USFDA Audit: Generic Drug Development Strategies

‘How to prepare for USFDA audit and inspection’ is a major question before many small and medium drug manufacturers who aspire to tap niche market of United States. There are certain potential traps, in which these manufacturers fall due to ignorance and limited knowledge. The author discuses major pitfalls to successful journey to USFDA approval for API as well as drug product manufacturers. The lecture also emphasizes strategies to overcome potential shortcomings, a drug manufacturer is tempted to commit.