by Dr. Yashashwini Reddy | Sep 15, 2025
FDA Forms Generally Used in Pharmaceutical Inspection 1. Form FDA 482 – Notice of Inspection Issued at the start of an inspection. Notifies the company that FDA investigators are officially beginning the inspection under the authority of the FD&C Act (Section...
by Dr. Yashashwini Reddy | Sep 15, 2025
Analytical Balances Drift and Its Importance 1. What is Analytical Balance Drift? Analytical balance drift refers to the gradual and unintentional change in the displayed weight reading of a balance over time, even without adding or removing material. This drift can...
by Dr. Yashashwini Reddy | Sep 15, 2025
4 Tips to Reduce 483 Observations The FDA issues Form 483 to highlight potential GMP violations observed during inspections. Minimizing these observations requires a proactive approach to compliance and quality culture. 1. Strengthen Documentation Practices Ensure...
by Dr. Yashashwini Reddy | Sep 15, 2025
Major Audit Findings about Equipment and Instruments in Pharmaceuticals Equipment and instruments are critical for ensuring product quality, reliability of test results, and compliance with cGMP. Regulatory inspections (FDA, EMA, MHRA, WHO) often highlight...
by Dr. Yashashwini Reddy | Sep 15, 2025
Critical Mistakes During Root Cause Investigation (RCI) Root Cause Investigation (RCI) is an essential step in pharmaceutical quality systems to identify, analyze, and eliminate the underlying causes of deviations, OOS, failures, or non-conformances. However, many...
