About Book
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.
About Author
Dr Ritu Gulia is currently working as Professor at South Point College of Pharmacy, Sonepat, Haryana. She has a total experience of 12 years including industry, academic and research. She completed her Bachelor's degree from M.D. University, Rohtak. She also completed her master's from Pt. B.D. Sharma University of Health Sciences, Rohtak and she earned her PhD. Degree from Chitkara University, Rajpura, Punjab. She has 04 Indian Design Patents to her credit. She has over 32 publications including research, review, and book chapters to her credit and presented papers at various prestigious pharmacy conferences. She has also published books for D. Pharmacy as well as B. Pharmacy course. She is a life member of IJDFR, IPA, APTI, IPGA. She is a promotional editor for many scientific journals. She also works as an external paper setter for various private universities. Her area of interest is bioavailability enhancement by various contemporary techniques and innovative drug delivery technologies.
Ms. Poonam Sandhu is currently working as an Associate Professor at South Point College of Pharmacy, Sonipat, Haryana. She has overall 8 years of teaching experience. She is also GPAT qualified. She has completed her Masters in Pharmacy (Pharmaceutics) from Kurukshetra University, Haryana and pursuing Ph.D. in Pharmaceutical Sciences at Maharishi Markandeshwar (Deemed to be University), Haryana. She has published various research and review papers in National and International journals. She has also presented posters in various National and International conferences.
Ms. Tilottama Bhattacharaya, Assistant Professor of Sister Nivedita University, relentlessly serving in the field of academics for last 7 years. She has worked in different reknowned Pharmacy colleges & universities of West Bengal. She was awarded Gold medal in Pharmcology in the year of 2018 under MAKAUT. She was the University topper of M.Pharm Pharmacology. She has collaborated her research work in various journals and book chapters. She is extremely dynamic and enthusiastic person who actively takes part in almost all academic activities. Her teaching abilities are worth mentioning with only objective to make her students stand apart in the crowd and shine bright in future. Her main objective for contributing in the book chapters is to make the B.PHARM subjects easier for the students and usher them with knowledge for their future development.
Dr. Viram Parmar is an educator with a deep interest in Industrial Pharmacy also he did his M. Pharma with Industrial Pharmacy specialization and doctorate in Novel Drug Delivery systems like Nasal in- situ gelling systems. He is having more than 18 years of experience in teaching to UG and PG students. Published more than 10 national and International Publications and attended more than 12 workshops and conferences. He has delivered lectures in different workshops and refresher’s courses.
He served up to 3-4 years as NSS programme officer and serving as Director of Social- NSS, Sports and Cultural Activities at Gyanmanjari Innovative University- Bhavnagar. He currently resides in Bhavnagar- India where he continues to professional.
Ms. Aditi Sharma is a committed researcher and educator who uses innovative methods. She holds a pharmacy master's degree in pharmacology. In her more than three years of experience, she has mentored more than twenty-five students on research projects that will help create the potential generation of pharmaceutical experts in the field. She is currently an Assistant Professor at FS University, Shikohabad's Shri Balaji College of Pharmacy and Research Centre. She has participated in an increasing number of workshops, seminars, and conferences nationally as well as internationally. Her knowledge is reflected in this work, which provides readers with concise, fact-based conclusions. Ms. Sharma is dedicated to integrating academic and industrial research, and keeps moulding the professionals of the future.
