by Dr. Yashashwini Reddy | Sep 10, 2025
🏭 Preparation for GMP Audit in Pharmaceuticals 1. Understand the Audit Scope Know whether it’s regulatory (FDA, EMA, MHRA, WHO, CDSCO), customer, or internal. Review previous audit/inspection reports and ensure CAPAs are implemented. Be aware of current guidelines,...
by Dr. Yashashwini Reddy | Aug 10, 2025
QC Audit Checklist 1. General Documentation & Records SOPs for all QC activities (latest approved versions, controlled copies). Records of training, competency assessments, and analyst qualification. QC logbooks (instrument usage, calibration, maintenance). Change...
