Modern Aspects of Pharmaceutical Quality Assurance

The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies.

This book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms. The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System

Serves as a guidance document for pharmaceutical manufacturing organizations and Quality Assurance students Provides correlation to a generic Standard Operating Procedure (SOP) Presents plant layouts to implement quality metrics for Pharmaceutical Manufacturing systems

Auteur

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.

Contenu
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.