Modern Aspects of Pharmaceutical Quality Assurance

Dr. Minal R. Ghante is presently working as I/c Principal and professor in Smt. Kashibai Navale College of Pharmacy, Pune. Her research areas include Quality Assurance, regulatory audits, drafting of Validation Protocols, Analytical method development, and validation by HPLC, LC-MS/MS, HPTLC, and Stability/Degradation Studies of APIs & Pharmaceutical Products. She has over 18 years of teaching and research experience at the undergraduate & postgraduate levels. She has more than 35 research publications in various Journals of National & International repute & authored/co-authored 12 books to her credit. She has presented more than 30 posters in multiple symposia/conferences. She is a recognized Ph.D. guide & Postgraduate Teacher at Savitribai Phule Pune University; 40 PG students have completed dissertations under her guidance. Dr. Manohar Anant Potdar is currently a Professor Emeritus in Smt. Kashibai Navale College ofPharmacy, Pune. His research areas include Plant Design and Operation, Production planning and Control systems, Pharmaceutical Validation, Good Manufacturing Practices, Plant Administration, Quality Assurance Techniques, Quality Planning and Analysis., Quality Management Systems, Pharmaceutical Quality Audits, and Regulatory Affairs. He has 33 years of industrial experience and ten years of teaching experience. He has authored nine technical books and nine library books. He is an approved guide for M.Pharm and Ph.D. and has mentored 34 M. Pharm students and one Ph.D. student for dissertation work. He is an expert in Production and Operation Management, Quality Assurance and Validation-Audits, Project Management, and Employee Training.  Dr. Vidhya Bhusari is an Associate Professor in Smt. Kashibai Navale College of Pharmacy, Pune. She has completed her Ph. D & M. Pharm from Bharati Vidyapeeth University, Pune, and has secured M. Pharm first classwith distinction. Her research areas include Quality Assurance, Analytical Method Development, and Validation by HPLC, LC-MS/MS, HPTLC, and Stability/Degradation Studies of APIs & Pharmaceutical Products. She has around five years of teaching experience and about six years of industrial experience. She has more than 40 research publications in various journals of International repute. She has authored one book to her credit. She has presented five posters and papers in multiple symposia/conferences. She has guided 12 M. Pharm students for their dissertation.

• Chater 1 Introduction: Quality Assurance from Perspective of Pharmaceutical Industry.- Chapter 2 Six-sigma Model in Pharma Industry (Part-I).-  Chapter 3. Six-sigma Model in Pharma Industry (Part-II).- Chapter 4 Developing a practical audit system for a pharmaceutical industry based on six system inspection model.- Chapter 5.- Compliance Tools to Assist the Drug Industry for Regulatory Audits from Developed Countries.- Chapter 6 Developing an Application Model for Planning, Controlling, Improving and Assuring Quality for Pharmaceutical Industry - covering Quality Planning and Quality Control.- Chapter 7 Developing an Application model for Improving Quality for Pharmaceutical Manufacturing based on the Quality principle- covering Quality Improvement and Quality Assurance Audit.- Chapter 8 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Tablets andCapsule Manufacturing Department.- Chapter 9 Developing a Design Qualification Protocol as Standard Operating Procedure for a Pharmaceutical Plant Facility Meeting cGMP requirement for Liquid oral and Ointment Department.- Chapter 10 Developing a simplified model Standard Operating Procedure to implement quality metrics for Pharmaceutical Manufacturing System .- Chapter 11 Documentation and data integrity in Pharmaceutical Industry.- Chapter 12 Quality Risk Management. Chapter 13 Deviation, Change control and CAPA.