About author : Dr. Rajeev Kumar, M. Pharm. (Pharmaceutics) Ph.D., is an academician and author. As an Assistant Professor at the Institute of Pharmacy, V. B. S. Purvanchal University in Jaunpur, UP, he has dedicated 19 years to the field of pharmacy education. Dr. Rajeev has authored many research papers in various national and international journals of repute. He has also presented his research at numerous national and international conferences and seminars. He is committed to providing his students with the knowledge and skills necessary to excel in their careers. Prof. (Dr.) Naresh Kalra is serving in the field of Pharmaceutical Sciences since last more than 15 years. He completed his graduation in Pharmacy from, Kurukshetra University, Kurukshetra and Post-graduation from Kurukshetra University, Kurukshetra. He has completed his Master of Business administration degree from Guru Jambheshwar University, Hisar. He has completed his doctorate in Pharmaceutical Sciences from SRU, Alwar. He is a life member of various pharmaceutical professional bodies like Association of Pharmaceutical Teachers of India (APTI), Indian Pharmacy Graduate Association (IPGA) Association of Pharmacy Professionals (APP) & Indian Pharmaceutical Association (IPA). He is also working as Editorial Board Member of various Journals of International repute. He has published more than 50 publications in Peer reviewed various National & International Journals. He has guided 8 Ph.D Scholars, 20 PG scholars, 35+ UG Students. & Five Research scholars are working under his guidance for doctoral work. Dr. Kalra delivered many lectures on various recent topics related to pharmaceutical field. He has been awarded with IPGA Promising Pharmacist Award, Best faculty of the Year award, Best Researcher Award, Innovative Teachers of the year award and many more. His area of research is Novel Drug Delivery: Nano-formulations, Analytical work, Transdermal, Buccal, Gastroretentive, Matrix tablets, Microspheres

About book : The "Textbook of Industrial Pharmacy-II" covers a wide range of topics important for understanding the industrial and regulatory aspects of pharmaceutical manufacturing. Here's an outline of the contents: 1. Pilot Plant Scale-Up Techniques: o General considerations for personnel, space, and raw materials. o Scale-up considerations and documentation for solids, liquid orals, and semi-solids. o SUPAC guidelines and platform technology. 2. Technology Development and Transfer: o WHO guidelines for technology transfer, including terminology, protocol, quality risk management, and processes from R&D to production (process, packaging, cleaning). o Documentation, premises, qualification, validation, and regulatory bodies involved in TT. o Indian TT agencies and relevant documentation, including confidentiality agreements, MoUs, and legal issues. 3. Regulatory Affairs: o Overview of regulatory authorities and their roles. o Responsibilities of regulatory professionals in drug development and approval. 4. Regulatory Requirements for Drug Approval: o Stages of drug development (non-clinical, clinical), IND and NDA applications, clinical protocols, and FDA submissions. 5. Quality Management Systems: o Concepts of quality management, QbD, Six Sigma, ISO certifications, NABL, and GLP. 6. Indian Regulatory Requirements: o Overview of CDSCO and State Licensing Authorities, COPP, and procedures for new drug approvals. This textbook provides a comprehensive guide to both the technical and regulatory challenges faced in industrial pharmacy.