About Book
Sterile Drug Product Manufacturing in Pharma Industry is a practical and comprehensive guide to the principles, processes, and regulatory expectations governing sterile pharmaceutical production. Covering everything from fundamental concepts—such as drug products, dosage forms, and quality requirements—to advanced topics including aseptic processing, terminal sterilization, cleanroom systems, environmental monitoring, validation, and packaging selection, this book presents complex subjects in a clear and structured manner. Designed for pharmacy students, manufacturing professionals, quality assurance personnel, and regulatory teams, it bridges the gap between academic knowledge and real-world industry practices. With a strong focus on compliance, contamination control, and process reliability, this book serves as an essential reference for anyone involved in sterile drug product manufacturing.
About Author
Dr. (Mrs.) Sushama Vaishnav (Hota) is a distinguished academician and researcher in pharmaceutical sciences with more than 18 years of teaching and academic experience at undergraduate and postgraduate levels. She is currently serving as Assistant Professor (M. Pharmacy – Pharmaceutical Quality Assurance) in the Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar. She holds a Ph.D. in Pharmacy, M.Pharm (Pharmaceutical Chemistry) with Gold Medal, and B.Pharm with Gold Medal, and is a GATE-qualified professional. In addition, she possesses a Bachelor of Laws (LL.B.) degree, which strengthens her expertise in pharmaceutical legislation, regulatory compliance, and quality systems. Dr. Vaishnav is an approved Ph.D. guide and postgraduate teacher, has guided M.Pharm dissertations, and has contributed to university syllabus development. Her scholarly work includes national and international publications, Scopus-indexed research articles, and a registered Indian patent. She is a registered pharmacist, a certified ISO 9001:2015 internal auditor, and a life member of the Indian Pharmaceutical Association and the Association of Pharmaceutical Teachers of India. Her academic and professional interests include pharmaceutical quality control, microbiology, analytical sciences, regulatory affairs, and quality management systems.