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
GMP Audit Checklist – Weighing & Dispensing 1. Area & Environment Weighing/dispensing area dedicated, controlled, and clearly labeled. Differential pressure maintained between adjacent areas. Environmental conditions (temperature, humidity, cleanliness)...
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...
by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Personnel & Premises 1. Personnel 1.1 Organization & Staffing Adequate number of trained and qualified staff available. Organizational chart available and updated. Clear roles, responsibilities, and reporting lines defined. 1.2 Training...
