by Dr. Yashashwini Reddy | Sep 13, 2025
Regulatory Affairs Audit Checklist 1. Regulatory Submissions & Approvals Dossier submissions (CTD/eCTD/ACTD) prepared and archived properly. Records of Marketing Authorization Applications (MAA), IND, NDA, ANDA, DMF, CEP maintained. Approval letters from health...
by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Regulatory Compliance in Pharmaceuticals: 8 Common Mistakes and How to Avoid Them Definition:Regulatory compliance in pharmaceuticals means adhering to laws, regulations, and guidelines (e.g., US FDA, EMA, WHO, MHRA, CDSCO) to ensure medicines are safe, effective,...
by Dr. Yashashwini Reddy | Sep 10, 2025
📊 Annual Product Quality Review (APQR / APR / PQR) in Quality Improvements 🔎 What is APQR / APR / PQR? A systematic, documented review of all licensed products conducted annually (or periodically) as per ICH Q10, EU GMP, and FDA requirements. Objective: To verify the...
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 9, 2025
✅ Areas to Inspect During Self-Inspection in Pharmaceuticals Personnel & Training Verify staff qualifications, training records, and adherence to GMP practices. Premises & Facilities Check cleanliness, maintenance, pest control, HVAC systems, and environmental...
