A Text Book of Industrial Pharmacy-II (B.Pharm 7th Semester)

The present book entitled“A Text Book of Industrial Pharmacy-II” was aimed to provide the knowledge of overall Industrial Pharmacy, different guidelines, Clinical Trials, Working areas and scope in pharmaceutical Industries etc., for the benefit of the student and society. The book covers the syllabus of B. Pharm 7 semester as prescribed by the Pharmacy Council of India. The language used in the book is very simple to be easily understood by the students with concepts. This book is divided into 5 units of Industrial Pharmacy-II as per PCI norms covering, Pilot plants and scale up technique, General considerations for different dosage forms, Technology development and Transfer, about different T.T agencies in India, Technology Transfer Protocol, Quality RiskManagement, T.T related documents, licensing,MoUs, Regulatory Affairs with history and overview, Regulatory requirements for drug approval, NDA, INDA, IB, Research Protocols, Quality Management Systemwith its Certifications, Total QualityManagement, Quality by design etc.The book also covers areas like State licensing authorities, Central drug standard and control organization, Certificate of Pharmaceutical Product, Regulatory requirements and approval procedures for newdrugs. Each chapter having key notes for providing additional information and for better understanding and learning the concepts and we have included question bank also (Multiple choice questions). Overall an attemptwasmade in this book to bring together all the knowledge and information fromvarious sources and present it in a simplified manner so that it become helpful to the students, faculties and all otherswho are interested in the field of Industrial Pharmacy