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
Vendor Audit Checklist 1. General Information Vendor profile and organization structure available. Valid licenses, registrations, and certifications (GMP, ISO, GDP). Regulatory inspection history (FDA, EMA, WHO, local authorities). Change notification procedure in...
by Dr. Yashashwini Reddy | Sep 13, 2025
USFDA Audit Preparation Checklist – Quality Control 1. Laboratory Infrastructure & Environment Lab layout complies with GMP (segregation of microbiology, chemistry, stability). Controlled access to QC labs (only authorized staff). Housekeeping and cleanliness...
by Dr. Yashashwini Reddy | Sep 13, 2025
Engineering / Maintenance Audit Checklist 1. Facility & Premises Preventive maintenance schedule for building, HVAC, and utilities. Cleanliness and upkeep of engineering areas (workshops, utility rooms). Access control to engineering/maintenance areas. Adequate...
