Abstract

REVIEW OF DATA INTEGRITY & CGMP VIOLATIONSFDA - PERSPECTIVE

Joharapuram Aneesa Chandini*, Dr. K. Uma Sankar and J. Praveen Kumar

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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 INDIA) and marketed in INDIA. 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, violation under [21 CFR & 211]. 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, Contemporaneous, Original, Attributable (ALCOA) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification (OOS) must be follow if any required.

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