About Book
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.
About Author
Dr. Ritesh Kumar is a Professor & Head in the department of Pharmaceutics at Sharda School of Pharmacy, Sharda University Agra, Uttar Pradesh with 19 years of teaching and research experience. He holds 12 Indian and 03 International patents, authored 8 books, and has over 35 peer-reviewed research/ review papers in various national and international journals with 1100+ citations on Google Scholar. He has been awarded the best research paper, best poster, and best faculty member for his outstanding contribution. His research interests include the formulation and optimization of gastroretentive, fast-release, and nanotechnology-based drug delivery systems. He has also been an invited speaker for many scientific meetings and conferences.
Dr. Devendra Kumar Bhopte is currently serving as Professor and Principal at the Sri Sathya Sai Institute of Pharmaceutical Sciences, RKDF University, Bhopal, Madhya Pradesh, India. He is a lifetime member of several professional organizations, including APTI, IPA, and Vigyan Bharti. Dr. Bhopte is actively involved in research and has published more than 12 articles in reputable national and international journals. He holds 2 patents and has presented approximately 21 papers and posters at various national and international conferences. Additionally, he has published 2 book chapters. Under his mentorship, 25 postgraduate students have completed their studies, and 6 research scholars are currently registered under his guidance. His research interests include Pharmaceutics, Novel Drug Delivery Systems, Microspheres, Nanoparticles, Liposomes, Patches, Hydrogels, and related areas.
Dr. D. Akila Devi is a distinguished academician and researcher with over 18 years of teaching and research experience. She earned her B.Pharm. and M.Pharm. with first class and university ranks, including a Gold Medal, and completed her Ph.D. from Dr. M.G.R. Medical University, Tamil Nadu. She has held various academic positions, including Professor and Head, and has contributed significantly to pharmaceutical sciences through 58 research publications, 25 conference papers, 4 textbooks, and 3 book chapters. Dr. Akila Devi has guided 52 M.Pharm. students and 3 Ph.D. scholars, with 4 more currently under her supervision. She holds three design patents and two published utility patents in novel drug delivery systems. Her academic excellence has been recognized with multiple awards, including the Best Teacher Award, Faculty Excellence Awards, and Avishkar Awards. She is an active member of several professional bodies and contributes to institutional development as a PCI inspector, NAAC/NBA coordinator, BOS member, and Nodal Officer for research. Dr. Akila Devi exemplifies professionalism, innovation, and dedication to education and societal advancement.
Anjali Naharwal is a Ph.D. Research Scholar in Pharmaceutics at Jamia Hamdard, New Delhi, with a strong academic foundation and three years of teaching experience in the field. She completed her M.Pharm from the College of Pharmacy, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana. Anjali has mentored several students, helping guide their academic and career paths, reflecting her commitment to education. Currently, she is actively engaged in a cancer research project, contributing to advancements in therapeutic development. While her focused specialization in pharmaceutics strengthens her depth of knowledge, expanding interdisciplinary collaboration could further enhance her research impact. Her growing portfolio shows promise for both academic and applied pharmaceutical sciences.
Dr. Vivekanand Katare is a seasoned academician and researcher with over 18 years of experience in the pharmaceutical field. He currently serves as the Director of Vivekanand College of Pharmacy, Ratibad, Bhopal, Madhya Pradesh. His academic journey includes a B.Pharm from Jiwaji University, an M.Pharm from Barkatullah University, and a Ph.D. from Sri Satya Sai University of Technology & Medical Sciences. Throughout his career, Dr. Katare has been actively involved in teaching, research, and academic leadership. His research interests lie in pharmaceutical formulation, drug delivery systems, and the development of herbal medicines. He continues to contribute significantly to the advancement of pharmacy education and innovation in drug research.
