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...
by Dr. Yashashwini Reddy | Sep 13, 2025
Line Clearance Audit Checklist – Manufacturing 1. General Area Readiness Production area cleaned and housekeeping records updated. Previous batch records, materials, and documents removed. No extraneous materials, labels, or components lying around. Garbage bins...
by Dr. Yashashwini Reddy | Sep 13, 2025
USFDA Audit Points / Observations 1. Data Integrity & Documentation Missing or incomplete raw data (e.g., deleted chromatograms, overwritten results). Audit trails not reviewed or disabled in computerized systems. Backdating, overwriting, or unauthorized...
