About Book
This textbook is designed to meet the curriculum requirements of undergraduate and postgraduate pharmacy programs, offering a structured and detailed approach to key topics such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), validation processes, documentation, auditing, regulatory affairs, and quality risk management. By bridging theoretical concepts with real-world applications, the book aims to prepare students for professional roles in both industrial and regulatory settings.
About Author
Ms. Shital D. Tiple, currently working as an Assistant professor in Institute of Pharmaceutical Education and Research,Wardha. She has 1 year industrial experience 5 years in teaching B. Pharmacy and M.Pharmacy. She has a qualified B.Pharmacy and M.Pharmacy in Quality Assurance branch from, Institute of Pharmaceutical Education and Research, Wardha affiliated to Rashtrasant Tukodoji Maharaj University Nagpur, Maharashtra, India. She has guided many students of B. Pharmacy at research level. Currently She has pursuing Ph.D. from Rashtrasant Tukodoji maharaj University Nagpur, Maharashtra, India. She has more than 3 publications and two books .
Dr. Abhishek Pandey is a Professor and Head of the Department of Chemistry and Pharmacy at Rani Durgavati Vishwavidyalaya, Jabalpur (Madhya Pradesh). He imparts his knowledge and expertise to aspiring students. He has 15 years of teaching experience in the field of Pharmaceutical Technology. Dr. Abhishek Pandey completed his Bachelor of Pharmacy from Guru Ramdas Khalsa College of Pharmacy, Jabalpur, Madhya Pradesh, India, and furthered his education by obtaining a master's in Pharmaceutics from Sri Sathya Sai College of Pharmacy, Sehore, Madhya Pradesh, and his doctoral degree from the Department of Pharmacy, Mansarovar Global University, Sehore, Madhya Pradesh, India. To enhance his professional growth, he completed a Diploma in Computer Science from the System Software Institute, Jabalpur, Madhya Pradesh. His passion for continuous learning and his commitment to professional development are evident from such things. His areas of expertise include Pharmaceutics, Scientific Writing,Pharmaceutical Engineering, and developing novel drug delivery systems for new drug compositions. He has in-depth knowledge of Pharmaceutics, Pharmaceutical Engineering, Quality Assurance, and Physical Pharmaceutics. He has published his research work in various national and international reputable journals, as well as many patents at the national and international levels.
Dr. Shilpi Sachdeva is a distinguished academician and researcher, currently serving as a Professor in Pharmacy at Sachdeva College of Pharmacy, Mohali, Punjab. With over 17 years of experience in academics, Dr. Sachdeva has established herself as a leading figure in pharmacy education. Dr. Sachdeva holds a Master's degree in Pharmacy (M. Pharm) in Quality Assurance from Rajasthan University of Health Sciences, Jaipur, and a PhD in Quality Assurance from Banasthali Vidyapith University, Vanasthali, Jaipur, Rajasthan. Her academic credentials and expertise have earned her numerous awards and honors, recognizing her contributions to the field. As a dedicated mentor, Dr. Sachdeva has guided over 40 M. Pharm students, shaping the next generation of pharmacy professionals. Her research work has been published in more than 10 reputed journals, and she has secured 2 patents, showcasing her innovative approach to research and development. As the author of the "TEXTBOOK OF PHARMACEUTICAL QUALITY ASSURANCE", Dr. Sachdeva brings her expertise and experience to the forefront, providing a comprehensive resource for students and professionals in the field of pharmaceutical quality assurance.
Prof. Priya Chhotulal Jain Completed her B Pharm from S.S.D.J college of pharmacy, Chandwad, Maharashtra, Pune University with G-pat qualified. And M Pharmacy from R.C.Patel College of Pharmacy, Shirpur, District-Dhule, Maharashtra, North Maharashtra University. Currently working as a Assistant Professor in North Maharashtra University With 8 year's of experience. She had Applied 2 Patents, 1 Article published in IJPRD peer review Journal, 1 Article published in Scopus Indexed, 1 paper publish in IPC, Bangalore, poster presentation in IPC, Bangalore also Attended various seminars and conferences.
Mr. Moidul Islam Judder currently holds the position of Assistant Professor in the Department of Pharmacy at the Royal School of Pharmacy, The Assam Royal Global University, located in Betkuchi, Guwahati-35, Assam, India. He earned his undergraduate degree in 2016 from the Faculty of Pharmaceutical Science, The Assam Downtown University in Panikhaiti, Guwahati-26, Assam, India, and completed his postgraduate studies in 2018 at the VELS Institute of Science, Technology and Advanced Studies (VISTAS) located on PV Vaithiyalingam Road, Velan Nagar, Krishnapuram, Pallavaram, Chennai, Tamil Nadu, 600117. With over 7 years of experience in teaching and research, he has made significant contributions to the field. His scholarly work includes the publication of over 27 research articles, 6 patents, and 4 books. He has also presented more than 13 oral and poster presentations at various conferences and symposia. Furthermore, he has guided more than 15 undergraduate students in their research endeavors.