3 Review(s)

The Textbook of Industrial Pharmacy-II is a comprehensive guide tailored for students, researchers, and professionals engaged in the pharmaceutical industry, focusing on critical areas of drug manufacturing and regulation. It delves into pilot plant scale-up techniques, highlighting key factors such as personnel and space requirements, raw materials, and process adaptation from laboratory to industrial scale for solids, liquids, and semi-solids. The book emphasizes the importance of proper documentation and introduces SUPAC guidelines and platform technologies, which are essential for ensuring consistent quality and compliance. It also offers an in-depth discussion on technology development and transfer (TT), referencing WHO guidelines and addressing granular processes for APIs, excipients, packaging materials, and finished products. The documentation, equipment qualification, validation, and regulatory agency roles are thoroughly covered, including insight into Indian TT bodies like APCTD and NRDC. A dedicated section on regulatory affairs explores their evolution, functions, and the responsibilities of professionals in the field. It examines the steps involved in drug approval, starting from preclinical development through IND and NDA submissions, and stresses the significance of clinical protocols, biostatistics, and data presentation in gaining FDA approval. Furthermore, the book discusses quality management systems, detailing modern quality tools like TQM, QbD, Six Sigma, and standard systems such as ISO 9000, ISO 14000, NABL, and GLP, essential for ensuring regulatory compliance and product excellence. Lastly, it elaborates on Indian regulatory requirements, shedding light on the organizational structure and role of CDSCO and State Licensing Authorities, with a focus on obtaining the Certificate of Pharmaceutical Product (COPP) and navigating the approval procedures for new drugs. This book is a valuable academic and practical resource for understanding the multidisciplinary scope of industrial pharmacy and its regulatory landscape.