Quality Assurance B. Pharmacy, Semester - VI

ISBN Number : 978-93-5299-779-4

Student Price : Rs.175

Student Dollar Price : 7$

Book Edition : First

Year of Publication : 2019

No. Of Pages : 148

About The Book

The purpose of this book is to introduce pharmacy students to the fundamentals of principles, practices and technologies involved in pharmaceutical quality assurance and its exploration from laboratory to global market. An integrated presentation is used in this textbook to demonstrate the interrelationships between various aspects of phartmaceutical quality assurance. An extensive overview of cGMP, QC tests, documentation, quality certifications and regulatory affairs is potentially presented in this book.

Each chapter of this book is written at a level consistent with the requirements of students being introduced to this area of study. Because this textbook often is used early in the professional curriculum, it contains important introductory topics, such as Quality Assurance and Quality Management concepts, Organization and personnel, Quality control, complaints and document maintenance and calibration and validation. Chapters are designed to provide opportunities for creative thought and application of the content.

The objective upon completion of the subject, student shall be able to:
1. understand the cGMP aspects in a pharmaceutical industry
2. appreciate the importance of documentation
3. understand the scope of quality certifications applicable to pharmaceutical industries
4. understand the responsibilities of QA and QC departments.

This book will also useful to all those students seeking to explore their carrier in pharmaceutical industries.

This book covers all the content which has prescribed by Pharmacy Council of India in New Syllabus All over India.

 

Contents -

1. Quality Assurance and Quality Management
2. Organization and Personnel
3. Quality Control and GLP
4. Complaints
5. Calibration and Validation

About The Author

Dr. Rajesh Shukla had completed B. Pharm. from S.R.N.S. College of Pharmacy, Bhind (R.G.P.V. University), M. Pharm. from RVS College of Pharmaceutical Science, Coimbatore (Dr. MGR Medical University, T.N.) and Doctorate in Pharmacy from Suresh Gyan Vihar University (Rajasthan). He is presently working as Associate Professor and Incharge of sophisticated analytical laboratory at Guru Ramdas Khalsa Institute of Science and Technology (Pharmacy) Barela, Jabalpur and having 10 year experience. He is life member of various professional organizations such as Association of Pharmaceutical Teachers of India (APTI), International Conference of Chemistry and Environment (ICCE) and Founder Member Association of Pharmacy Professionals (APP). He has guided 12 PG students.

Dr. Vikas Pandey had completed B. Pharm from Department of Pharmacy, Barkatullah University, Bhopal, M.P, M. Pharm. from Department of Pharmacy, Annamalai University, Chidambaram, T.N. and Doctorate in Pharmacy from School of Pharmacy, Suresh Gyan Vihar University, Jaipur, Rajasthan. He is presently working as Associate Professor and Incharge (Drug Delivery and Nanotechnology Laboratory) at Guru Ramdas Khalsa Institute of Science & Technology (Pharmacy), Jabalpur, M.P. and having 11 year experience. He had also worked as Production Officer at Glenmark Pharmaceuticals, Nashik, Maharashtra. He is life member of Association of Pharmaceutical Teachers of India (APTI).

Dr. Gopal Rai is the Professor of Pharmaceutics and Principal at College of Pharmacy, Guru Ramdas Khalsa Institute of Science & Technology (Pharmacy), Jabalpur, M.P. He is Fellow of Association of Pharmaceutical Teachers of India (APTI) and Life Member of Indian Pharmaceutical Association (IPA). Dr. Rai is serving pharmacy academics over last more than 15 years and guided 25 PG students. He has successfully accomplished various national level research projects funded by Department of Biotechnology, Department of Science and Technology and Madhya Pradesh Council of Science and Technology. He has extensively worked in the field of Pharmaceutical Sciences and has contributed number of research and review article publications in high reputed international and national journals.

Mr. Ajay Kumar Shukla had completed B. Pharm. from Guru Ramdas Khalsa Institute of Science & Technology (Pharmacy), Jabalpur, M.P., M. Pharm. from NRI Institute of pharmacy, Bhopal. He is presently working as Assistant Professor at Guru Ramdas Khalsa Institute of Science & Technology (Pharmacy), Jabalpur, M.P. and having 7 year experience. He is life member of Association of Pharmaceutical Teachers of India (APTI) and Association of Pharmacy Professionals (APP).

He has guided 6 PG students. He has participated in various National and International conferences. He has extensively worked in the field of Pharmacy and has contributed number of research and review article publications in high reputed international and national journals, along with books.

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