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Quality in Generic Pharmaceuticals: Part 4

Every year patents for branded drugs continue to expire and with each expiration, the generics market expands ever larger. As the market grows, the focus on the quality and safety of generics grows with it. Today, the U.S. generic market is the largest in the world with nearly $70 billion in annual revenue. The Food and Drug Administration (FDA) enforces a rigorous process for validating generics and ensuring their effectiveness. From the time of development through production, generics are held to the same high standard for Safety, Quality, Identity, Potency, and Purity (SQUIPP) as branded products.

In this fourth iteration of Quality in Generic Pharmaceuticals, Clarkston Consulting continues to examine the trends and shifts in the oversight and quality of the generic market through the analysis of inspection data from the FDA. This study examines FDA inspections by center, focus area, and result. The purpose of this study is to analyze and assess inspection data year over year with consideration to relevant industry trends over the past five years. The data analyzed for this report comes from the FDA’s inspection database, specifically utilizing data from October 2013 to September 2014 compared to inspection data from October 2014 to September 2015.

To read the rest of this research, download the PDF below.

Tags: Data Integrity, Quality Operations