FDA WARNING LETTER ANALYSIS: A TOOL FOR GMP COMPLIANCEAbstract
In the past few years, the US Food and Drug Administration has issued more warning letters, import alert & seizure to manufacturers of finished product for violation of the current good manufacturing practice regulation. Indian and US Pharmaceutical Manufacturer’s Warning letter from the FDA’s Electronic Reading Room were selected as case study and was analyzed for non-compliance of GMP with 21 CFR 211 and inspection systems. A detailed review of selected Indian and US Pharmaceutical Manufacturer warning letters provides a numbers of useful insights into where the FDA is presently focusing, where Indian Pharmaceutical Manufacturer having lack of compliance and at where Indian Pharmaceutical Manufacturer having stringent compliance. Reviewed and analyzed letters shows that the FDA is taking a more systemic based approach to assessing GMP compliance and paying close attention to such area as the Quality System. Based on review and analysis of selected Warning letter’s deficiencies, I believe that pharmaceutical companies, by carefully assessing FDA GMP warning letters from the past year & base on this assessment companies should develop compliance check list/data/trends and incorporate this in internal inspection/compliance program for the clues about how they can enhance their GMP compliance and more effectively manage future FDA establishment inspection and avoiding the non-compliance of GMP or FDA-483 from FDA inspection.