In the past one year, the U.S. Food and Drug Administration (FDA) has issued more than 25 Warning Letters to active pharmaceutical ingredients (APIs) and finished pharmaceutical manufacturers for violations of the current good manufacturing practice (GMP) regulations.A careful review of these Letters provides a number of useful insights into where the FDA is currently focusing its limited GMP enforcement resources.
Some key issues to consider from GMP Warning Letters:
The FDA issued GMP Warning Letters to domestic facilities, not concerning about many issues that have been raised in the past 12 months about the increasingly global nature of pharmaceutical manufacturing
Several GMP Warning Letters incorporated compliance issues like unapproved new drugs, misbranded drugs, promotional issues, pharmacy compounding which demonstrates that the FDA is taking a more holistic approach to enforcement when it identifies violative conduct.
The FDA shows major concern about final production instead of the global supply chain for manufacturing of pharmaceutical products as it issued majority of warning letters to finished product manufacturers rather than Active Pharmaceutical Ingredients (API) manufacturers.
The FDA is interested in taking risk-based approach to assess GMP regulations and paying close attention towards the areas like Quality control unit, process validation, and laboratory out of specification (OOS) investigations.
It is to be expected that the pharmaceutical companies enhance their manufacturing processes, production value, and quality systems and carefully manage Future FDA inspections.
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