Text Book Of Industrial Pharmacy-Ii

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.