by Dr. Yashashwini Reddy | Sep 10, 2025
👥 Checklist for Audit in HR / Admin (Pharmaceuticals) 1. Organization & Policies ✅ Organization chart updated and approved. ✅ HR policies documented (recruitment, promotion, disciplinary action). ✅ Job descriptions (JDs) defined, approved, and role-specific. ✅...
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
🔐 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
🧾 Common FDA 483 Observations Related to Cleaning in Pharmaceuticals 1. Inadequate Cleaning Validation Cleaning validation not performed for all product-contact equipment. Worst-case product selection (hardest to clean, most toxic/potent, least soluble) not justified....
