"Textbook of Industrial Pharmacy-II" is an in-depth guide that covers crucial aspects of industrial pharmacy. The book begins with an exploration of pilot plant scale-up techniques, delving into general considerations, SUPAC guidelines, and platform technology. It progresses to technology development and transfer, including WHO guidelines, quality control, and practical aspects of commercialization. The book also provides a comprehensive overview of regulatory affairs, detailing the role and responsibilities of professionals in this field, and the regulatory requirements for drug approval, including clinical research protocols and FDA submissions. Additionally, it delves into quality management systems, discussing concepts like Total Quality Management and Six Sigma, and concludes with an examination of Indian regulatory requirements, highlighting the roles of CDSCO and State Licensing Authority. This textbook is an essential resource for students and professionals in the pharmaceutical industry, offering a thorough understanding of the complexities and standards in industrial pharmacy.
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Prof. Shital V. Sirsat, Dr. Vivek Puri, Prof. Sandip B. Sapkal, Prof. Shital Ganesh Dhanmane, Prof. (Dr.) Prashant Mathur
Prof. Shital V. Sirsat is a respected Associate Professor at Shri Sant Gajanan Maharaj College of Pharmacy, Buldana, Maharashtra. He began his academic career with a Bachelor's in Pharmacy from Government College of Pharmacy, Aurangabad, in 2000, and later excelled in the GATE-2004 with a 96 percentile. Prof. Sirsat furthered his education with a Master's in Pharmacy, specializing in Biopharmaceutics, from Government College of Pharmacy, Karad, graduating in 2006. His dedication to education and research significantly contributes to the field of Pharmaceutical Science.
