About Book
The textbook “Pharmaceutical Quality Assurance” has been designed in accordance with the Pharmacy Council of India (PCI) regulations and syllabus prescribed for Third Year B. Pharm, Semester VI students. This book serves as a comprehensive and systematic guide to understanding the principles, practices, and regulatory frameworks that govern quality systems in the pharmaceutical industry.
Pharmaceutical Quality Assurance is a critical discipline that ensures the safety, efficacy, and reliability of medicinal products from development through distribution. The book provides an in-depth exploration of quality concepts such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Quality Control (QC), Validation, Calibration, Documentation, Quality Risk Management, and Regulatory Compliance. It bridges theoretical understanding with industrial application, helping students connect classroom learning to real-world pharmaceutical operations.
This book aims not only to fulfill academic requirements but also to prepare students for professional roles in the pharmaceutical industry, regulatory affairs, and quality management. By emphasizing both national and international standards such as WHO, ICH, USFDA, and ISO, it equips learners with the knowledge to meet global expectations in quality assurance practices.
About Author
Mr. Mahendra Singh has done his schooling from B.S.N. Hr. Sec. School, Kotma Colliery, Distt.- Anuppur (MP), Bachelor of Pharmacy Shri RNS College of Pharmacy, Gormi, Bhind (MP) and Master of Pharmacy from Vel's College of Pharmacy, Pallavaram, Chennai, (TN) under "The Tamil Nadu Dr. MGR Medical University", Chennai. He has 02 years of teaching & more than 15 years of pharmaceutical Industrial experience as Quality Assurance Personal in Dosage forms like Oral Solids, Oral Liquids and Transdermal in organization like Torrent Pharmaceuticals Ltd., Abbott Healthcare Pvt. Ltd, SIDMAK Laboratories (I) Pvt. Ltd. and Akums Drugs & Pharmaceuticals Ltd. He has faced many international GMP Inspections like USFDA (United States), EMA (European Union), ANVISA (Brazil), MCA (TGA (Australia), The Ministry of Health-Minzdrav (Russian Federation), etc. He has 01 Indian Design Patent and 14 Research/Review article publications in his Quiver. He is the co-author of the book "Textbook for Pharmacognosy and Phytochemistry". Apart from this, he has attended many conferences/seminars too in his tenure so far.
Mr. Priyesh Pankaj has done B. Pharmacy from Sree Sidhganga College of Pharmaceutical Science, Tumkur(University- RGUHS) , Bangalore, Karnataka & M. Pharmacy in Pharmacognosy from "Manipal college of Pharmaceutical Sciences, Manipal", Udupi-Karnataka. He has also qualified GATE exam. He is a Registered Pharmacist of Pharmacy Council of India. He has approx. 20 years of pharmaceutical Industrial experience as Quality Assurance Personal in Dosage forms like Oral Solids, Oral Liquids in organisation like Torrent Pharmaceuticals Ltd. During this tenure he has faced many international audit like European Union, WHO, ANVISA (Brazil), MCA ( Zimbabwe), NAFDAC (Nigeria) , MOH (Sudan), Ministry of Health, (Ukraine), Ministry of Health (Uganda) & TGA ( Australia). He has 01 International Research paper publications too. Apart from this, he has attended many conferences/seminars too in his tenure so far.
Mr. Tulsi Das Patel has done B. Pharmacy from "Department of Pharmacy, Barkatullah University”, Bhopal (M.P.)” & M. Pharmacy (Pharmacognosy) from "Department of Pharmacy, Barkatullah University”, Bhopal (M.P.). At present, he is associated with G.S. Pharmbutor Pvt. Ltd., Behror, Rajasthan as a Quality Assurance Personal. He has 19 years of pharmaceutical Industrial experience as Quality Assurance Personal in Dosage forms like Oral Solids, Oral Liquids, External Liquids, Semisolid, Powder and Transdermal. He has 01 Research/Review articles. He has attended many conferences/seminars too in his tenure so far.
