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
📌 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
📌 Deviation Control in Pharmaceuticals Definition:Deviation control in pharmaceuticals refers to the systematic process of identifying, documenting, investigating, and resolving any departure from approved processes, procedures, or specifications in a GMP-regulated...
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
👥 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. ✅...
