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...
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...
by Dr. Yashashwini Reddy | Sep 13, 2025
Liquid Production Audit Checklist 1. Facility & Environment Production area designed as per GMP (segregated zones, unidirectional flow). Cleaning and sanitization records of manufacturing & filling areas available. Air Handling Units (AHUs) qualification and...
