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The Textbook of Industrial Pharmacy–II provides a comprehensive and structured insight into the critical aspects of industrial pharmaceutical practices. It begins with pilot plant scale-up techniques, highlighting the importance of scaling formulations from laboratory to production scale, covering personnel, space, raw materials, and regulatory documentation. Special attention is given to scale-up processes for various dosage forms such as solids, liquid orals, and semisolids, including compliance with SUPAC (Scale-Up and Post-Approval Changes) guidelines and the emerging role of platform technologies. The second unit, Technology Development and Transfer (TT), outlines WHO protocols for transferring pharmaceutical technologies from R&D to manufacturing. It details the roles of quality risk management, analytical method transfer, and validation. Important components such as API, excipients, packaging, and documentation are discussed, alongside legal frameworks including confidentiality agreements, licensing, and MoUs. The section also explores Indian TT agencies like APCTD, NRDC, and BCIL. Regulatory Affairs forms the third section, offering a historical perspective and an overview of global regulatory bodies. It emphasizes the function and responsibilities of regulatory professionals and the importance of their involvement across product lifecycle stages. The fourth chapter details the regulatory requirements for drug approval, addressing components such as INDs, NDAs, investigator brochures, non-clinical pharmacology, toxicology, and biostatistics. It also explains the management and design of clinical protocols, BE studies, and data presentation for FDA submissions. In the fifth section, Quality Management Systems are discussed extensively. Topics include Total Quality Management (TQM), Quality by Design (QbD), Six Sigma, Out of Specification (OOS) handling, change control, and compliance with ISO standards (9000 and 14000 series), NABL, and GLP practices. This ensures students understand how to maintain and evaluate quality at every stage of product development and manufacturing. Lastly, the textbook addresses Indian Regulatory Requirements, with a focus on the Central Drug Standard Control Organization (CDSCO) and State Licensing Authorities. It covers their structure, responsibilities, and role in issuing Certificates of Pharmaceutical Product (COPP), along with procedures for new drug approval in India. This well-organized content makes the textbook a valuable resource for students, educators, and professionals, bridging academic knowledge and industrial application.