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...
by Dr. Yashashwini Reddy | Sep 13, 2025
Warehouse Audit Checklist 1. General Warehouse Practices SOPs available and followed for receipt, storage, dispensing, and distribution. Warehouse access restricted to authorized personnel. Cleanliness and housekeeping maintained as per GMP. Pest control records...
