This book comprehensively explores the regulatory frameworks governing pharmaceutical manufacturing, quality control, and approvals in Indian pharmaceutical scenarios. Tailored for industry professionals, students, and researchers, it bridges the knowledge gaps in regulatory affairs in the pharmaceutical industry. Covering key topics such as pilot plant scale-up, SUPAC (Scale-Up and Post Approval Changes), technology transfer, regulatory requirements, and quality management systems, it offers insights into navigating the complexities of Indian regulatory requirements. A must-read for those aiming to excel in pharmaceutical regulation, the book serves as a roadmap for ensuring efficiency, safety, and compliance in pharmaceutical industries operating in India.
Auflage
Sprache
Verlagsort
Newcastle upon Tyne
Großbritannien
Zielgruppe
Editions-Typ
Produkt-Hinweis
Maße
Höhe: 212 mm
Breite: 148 mm
ISBN-13
978-1-0364-5528-6 (9781036455286)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Dr Madhu Verma, an accomplished academic and researcher, is a Professor at I.T.S College of Pharmacy, Muradnagar, India. She is an alumna of M.D. University, Rohtak, Haryana, and earned her PhD from Dr A.P.J. Abdul Kalam Technical University (AKTU), Lucknow, Uttar Pradesh, both India. She has 17 years of expertise in academia and has authored and published over 30 research and review articles in esteemed national and international journals. Her scholarly contributions extend to presenting papers and participating in numerous prestigious conferences, workshops, seminars, Faculty Development Programs (FDP), Quality Improvement Programs (QIP), and Massive Open Online Courses (MOOCs). Dr Iti Chauhan is currently serving as a Professor, at I.T.S College of Pharmacy, Muradnagar, Ghaziabad, India. The author possesses over 16 years of teaching experience in academics and research projects. She completed her Doctoral Research work in Pharmaceutical sciences (PhD) from Kharvel Subharti College of Pharmacy, Swami Vivekanand Subharti University, Meerut, India. She holds a Bachelor of Pharmacy degree from I.E.T MJPRU (Mahatma Jyotiba Phule Rohilkhand University), Bareilly, India and a Master of Pharmacy degree from RKGIT (Raj Kumar Goel Institute of Technology), Ghaziabad. She has authored three books and three book chapters, and presented papers and attended various national and international conferences, workshops, and seminars.
