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...
by Dr. Yashashwini Reddy | Sep 13, 2025
Regulatory Affairs Audit Checklist 1. Regulatory Submissions & Approvals Dossier submissions (CTD/eCTD/ACTD) prepared and archived properly. Records of Marketing Authorization Applications (MAA), IND, NDA, ANDA, DMF, CEP maintained. Approval letters from health...
