by Dr. Yashashwini Reddy | Sep 15, 2025
Preparation for GMP Audit in Pharmaceuticals Good Manufacturing Practice (GMP) audits are crucial checkpoints that ensure pharmaceutical companies comply with regulatory standards (FDA, EMA, MHRA, WHO). Proper preparation reduces the risk of critical observations and...
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...
by Dr. Yashashwini Reddy | Sep 15, 2025
Why Data Integrity is More Important Than Ever? Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle. In today’s highly regulated pharmaceutical and healthcare environment, data integrity has become more important than...
