by Dr. Yashashwini Reddy | Sep 10, 2025
💧 Guide to Inspections of High Purity Water Systems 1. System Design & Qualification ✅ Is the system designed with sanitary construction (316L SS, orbital welding, sloped piping, drainability)? ✅ Has the water system undergone DQ, IQ, OQ, and PQ? ✅ Are P&IDs...
by Dr. Yashashwini Reddy | Sep 10, 2025
🏭 Checklist for Internal Audit / Self-Inspection (Defects & Regulatory Compliance) 1. Documentation & Data Integrity ✅ Are records complete, contemporaneous, and accurate (ALCOA+ principles)? ✅ Any overwriting, missing data, or backdated entries? ✅ Are...
by Dr. Yashashwini Reddy | Sep 10, 2025
🔎 Major Audit Findings – Equipment & Instruments 1. Qualification & Validation Issues Missing or incomplete DQ/IQ/OQ/PQ records. Equipment used without initial or periodic requalification. Validation protocols not followed or not approved before execution....
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...
