by Dr. Yashashwini Reddy | Sep 10, 2025
⚖️ Analytical Balance Drift 🔎 What is Drift? Drift refers to the gradual change in the displayed weight reading of an analytical balance over time without any actual change in the sample’s mass. It is typically observed when the balance reading keeps increasing or...
by Dr. Yashashwini Reddy | Sep 10, 2025
🔴 Critical Mistakes in Root Cause Investigation (RCI): Jumping to Conclusions – Assuming the cause without evidence or proper investigation. Superficial Investigation – Stopping at symptoms instead of identifying the true underlying cause. Poor Documentation –...
by Dr. Yashashwini Reddy | Sep 9, 2025
⚠️ 5 Most Common FDA 483 Observations in Pharma 1. Inadequate Investigations (OOS / Deviations / Complaints) Failure to thoroughly investigate out-of-specification (OOS) results, deviations, or complaints. Root cause analysis either incomplete, unjustified, or not...
by Dr. Yashashwini Reddy | Sep 9, 2025
🔐 Why Data Integrity is More Important Than Ever? 1. Patient Safety at the Core Medicines are only as safe as the data proving their quality. Any falsified, incomplete, or inaccurate record may lead to unsafe products reaching patients. Strong data integrity ensures...
by Dr. Yashashwini Reddy | Sep 9, 2025
🏭 How FDA Inspections are Conducted in Manufacturing Facilities 1. Pre-Inspection Phase FDA identifies facilities to inspect based on: Risk-based selection (product type, compliance history, criticality, recalls, complaints). New drug approval or pre-approval...
