About book : This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad

About author : 1.) Dr. S. Valarmathi MPharm, Ph.D is serving in the Department of Pharmaceutics with experience of more than 16 years in academics and research. She has received her Bpharm and Mpharm from The Tamilnadu Dr.MGR Medical university.Chennai and Ph.D from VELS University . She has awarded for various paper presentation in international and national conferences. She has good number of research paper publications in national and international journals. She is an author of many Pharmaceutics books and book chapter. She is a reviewer and editor of various journals of repute. She is a recipient of Academic Excellence Award 2022 from INSC Scholars. Guided good number of B.Pharm and M.Pharm project students. Currently she is serving as a Professor in the Department of Pharmaceutics at Annaiveilankanni’s Pharmacy College. Chennai. 2.) Dr. Anasuya Patil. M.Pharm., Ph.D., working as Associate Professor, Department of Pharmaceutics, KLE College of Pharmacy, Bengaluru, Karnataka. She is having more than 20 years of teaching experience and has been guiding many PG and Ph.D scholars in the department of Pharmaceutics. She had worked in formulation development at pharmaceutical industry. She has published several research papers in reputed journals, contributed as author to Pharmaceutical Quality Assurance book and in her credit one Indian Patent. 3.) Dr. Abhishek Suman has done B.Pharm from M.I.T, B.R.A.B university, Muzaffarpur and M. Pharm from I.F.T.M, U.P.T.U, Lucknow followed by PhD from I.F.T.M University, Moradabad, U.P. He was awarded Dr. P. D. Sethi Memorial Annual National award 2019 for his contribution in the field of Pharmacy, herbal and pharmaceutical analysis. Currently, he is working as post graduate faculty at Govt. Pharmacy Institute, Patna, Bihar. He has 15+ year of experience of teaching and pharmaceutical manufacturing. He has published various research papers in national and international journals and presented papers in different national and intern