A Theoretical Book on Quality Assurance

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Author: Dr. Abhijeet Ojha, Ms. Karuna Dhaundhiyal, Mrs. Sarita Rawat Dharmshaktu, Dr. Arun Kumar Singh
Publisher: IP Innovative Publication Pvt. Ltd.
Edition: First
ISBN-13: 9788119613496
Publishing year: 2024
No of pages: 135
Weight: 220 g
Book binding: Paperback

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1. Dr. Abhijeet Ojha is working as Principal Amrapali Institute of Pharmacy and Sciences, Haldwani, Uttarakhand. He is having more than 18 years of teaching experience in reputed academic organisations. He served as Principal at Six Sigma Institute of Technology and Science, Rudrapur, Uttarakhand and as Assistant Professor in GRDIMT and DIT University, Dehradun, Uttarakhand. He has completed his PhD from Uttarakhand Technical University, M.Pharm from Bundelkhand University, Jhansi, B.Pharm from Kumaun University Nainital, Uttarakhand, MBA in HR from Sikkim Manipal University, M. Phil from Nagaland University, PG Diploma in Marketing from Pondicherry University and PG Diploma in IPR from BII, Noida, Uttar Pradesh. He has qualified GATE examination in 2005. He is a life time member of APTI, IPA (Executive council member), ACPI and Vice President, APTI Uttarakhand state branch (2022–2027). He has published 15 books for D.Pharm and B.Pharm students as per PCI norms and he has published 8 book chapters with reputed publishing house like Elsevier. Moreover he has published more than 60 papers in national and international journals and granted four design patents. He is having seven awards in his credit; Award of Emerging Leader and Author, Academic Excellence Award,Young Principal of the Year Award, Outstanding Teacher Award, Professor of the year Award, Excellence in Academic and Research Award. He has supervised several M.Pharm and B.Pharm students, organized around 15 national and international webinars and seminar at college level. He has attended several workshops and faculty development programs and registered as pharmacist in Uttarakhand State Pharmacy Council. 2. Karuna Dhaundhiyal is working as an Assistant Professor in Amrapali Institue of Pharmacy and Sciences, Haldwani, Uttarakhand. She is having 2 years of teaching experience in reputed academic organization. She is pursuing her PhD from Graphic Era Hill University, Dehradun. Uttarakhand. She has completed her M.Pharm from Kumaun University, Bhimtal, Uttarakhand and B.Pharm from Shri Guru Ram Rai Institute of Technology and Sciences, Dehradun, Uttarakhand. She is a life time member of APTI. She has published 2 book chapters with reputed publishing house like Springer. She has published one paper in international journal and one patent. She has attended several webinars, international conferences and faculty development programs and registered as pharmacist in Uttarakhand State Pharmacy Council. 3. Mrs. Sarita Rawat Dharmshaktu, is working as an Assistant Professor in Amrapali Institute of Pharmacy and Sciences, Amrapali Group of Institutes, Haldwani, Uttarakhand. She has done her Bachelors of Pharmacy from H.N.B.G Central University Srinagar, Uttarakhand and Masters of Pharmacy from SGRRITS, Dehradun, Uttarakhand. She is pursuing her Ph.D from Suresh Gyan Vihar University, Jaipur, Rajasthan. She has more than 5 years of academic experience along with 3 years of research experience in various domains of pharmacy. She is life time member of APTI. Prior to join Amrapali Group of Institute, Haldwani, she served as an Assistant Professor in Suresh Gyan Vihar University, Jaipur, Rajasthan, for three years in School of Pharmacy. Her area of research interest is patient centric, clinical and pre-clinical trials, and she has carried out studies on diabetes, epilepsy and she is expertise in patient counselling, ADR monitoring. She has published more than 20 research publications in national and international journals, 3 Indian Patent and 6 book chapters in Elsevier and Springer. She is editorial board member in PBI journal. Her key area of research is in Pharmacy Practice and Pharmacology. She has supervised several B.Pharm students and organised 4 national webinars. She has attended several workshops and faculty development programs and registered as pharmacist in Uttarakhand state pharmacy council. 4. Dr. Arun Kumar Singh is currently working as a Professor and HOD at Faculty of Pharmacy and Sciences at Amrapali group of institutes, Haldwani, Uttarakhand Dr. Arun Kumar Singh holds Ph.D. in Pharmacy from Kumaun University, Nainital, Uttarakhand. He has pursued his post-graduation and graduation from Uttar Pradesh Technical University, Lucknow. He has qualified Graduate Aptitude Test in Engineering (GATE) in 2008 with more than 95 percentile. He has credited three published Patents and 30 International/National Research papers in peer-reviewed journals along with authors of books. He has also attended many conferences, FDPs and workshops and supervised 50 UG and 20 PG students. In the year 2015, Dr. Arun Kumar Singh was awarded with renowned Young Scientist Award in 9th USSTC, Uttarakhand State Council for Science & Technology (UCOST), Dehradun. He also worked as Research Chemist in Ranbaxy clinical pharmacology unit, Fortis Hospital, Noida, Uttar Pradesh. He has 15 years of professional experience in various domains of pharmacy. He has worked as Project organizing secretary “INSPIRE INTERNSHIP-2014” sponsored by DST, Govt. of India and coordinator for organizing a seminar/conferences and workshops. His area of research interest is biopolymer isolation, Nano-formulation and phospholipid complexation based dosages form development.

<p>The book “A Theoretical Book on Quality Assurance” is designed especially for 6th Semester B.Pharma students as per PCI course regulations. It reflects a comprehensive description and an overview of the existing knowledge of quality assurance making it appropriate for institutional purpose. This book consists of all the five units from Pharmaceutical Quality Assurance. Unit 1 deals with Quality Assurance and Quality Management concepts, Total Quality Management ICH guidelines. Unit 2 deals with Organization and Personnel, Premises, Equipment and Raw Material. Unit 3 deals with Quality Control and Good Laboratory Practices. Unit 4 deals with Document maintenance in Pharmaceutical industry. Unit 5 deals with Calibration and Validation. At the end of each unit examination oriented questions in the form of short answer type questions, long answer type questions and multiple choice questions are prepared.<br></p>