by Dr. Yashashwini Reddy | Sep 15, 2025
Preparation for GMP Audit in Pharmaceuticals Good Manufacturing Practice (GMP) audits are crucial checkpoints that ensure pharmaceutical companies comply with regulatory standards (FDA, EMA, MHRA, WHO). Proper preparation reduces the risk of critical observations and...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Equipment Design & Installation Equipment designed with GMP-compliant sanitary design (easy to clean, non-reactive materials). Materials of construction suitable (e.g., SS 316L for product contact). Installation Qualification (IQ) completed and documented....
by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Process Validation 1. General Requirements Validation Master Plan (VMP) available, approved, and up to date. Validation activities aligned with regulatory guidelines (USFDA, EMA, WHO, ICH Q8–Q10). Validation performed for all critical processes...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Area & Environment Filling/packaging areas designed to prevent mix-ups and contamination. Environmental conditions (temperature, humidity, differential pressure) monitored. Cleanliness of the area maintained before, during, and after operation. Adequate...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. System Design & Validation Water system (Purified Water, WFI, Potable Water) designed to meet pharmacopeial requirements (USP/EP/IP/JP). System qualification performed (DQ, IQ, OQ, PQ) with proper documentation. Risk assessment performed for potential...
