by Dr. Yashashwini Reddy | Sep 13, 2025
Line Clearance Audit Checklist – Manufacturing 1. General Area Readiness Production area cleaned and housekeeping records updated. Previous batch records, materials, and documents removed. No extraneous materials, labels, or components lying around. Garbage bins...
by Dr. Yashashwini Reddy | Sep 13, 2025
Liquid Production Audit Checklist 1. Facility & Environment Production area designed as per GMP (segregated zones, unidirectional flow). Cleaning and sanitization records of manufacturing & filling areas available. Air Handling Units (AHUs) qualification and...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Contamination Issues in Pharmaceutical Production and Their Prevention Definition:Contamination in pharmaceuticals refers to the undesired introduction of chemical, microbial, or physical material into drug products during manufacturing, packaging, storage, or...
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...
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. ✅...
