PharmaTutor
14 July 2016

A REVIEW ON USFDA WARNING LETTER AND VIOLATION OBSERVED IN PHARMACEUTICAL INDUSTRY

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ABOUT AUTHORS
Suleman S. khoja 1, Sohil S khoja 1,Parthkumar H chauhan 2,Farhad S Khoja
1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
2Resource person in quality assurance ,NAVSARI, Gujarat.
3Registered Pharmacist ,VAPI, Gujarat.
premukhoja@gmail.com

ABSTRACT
A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.

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