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
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
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
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 11, 2025
📌 Contamination Issues in Pharmaceutical Production and Their Prevention Definition:Contamination in pharmaceuticals refers to the undesired introduction of chemical, microbial, or physical material into drug products during manufacturing, packaging, storage, or...
