by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Definition:cGMP (Current Good Manufacturing Practices) are the regulations enforced by regulatory authorities (like US FDA, EMA, WHO, MHRA, CDSCO, etc.) to ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Change Control in Pharmaceuticals Definition:Change Control is a systematic approach to managing all changes made to processes, equipment, systems, or documents in the pharmaceutical industry to ensure compliance with Good Manufacturing Practices (GMP), product...
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
🏭 GMP Audit Checklist – Storage of Starting Materials 1. Material Receipt & Identification ✅ Are incoming starting materials received against approved suppliers and purchase orders? ✅ Are materials inspected for damage, tampering, contamination, and labeling...
