If you're a B. Pharm or M. Pharm student seeking a comprehensive yet concise guide to the regulatory aspects of pharmaceutical quality systems, look no further than Regulatory Aspects of Pharmaceutical Quality System - Brief Introduction. While other textbooks on quality assurance cover a variety of topics to varying degrees of depth, this book provides a unified approach that is both insightful and practical. Designed to meet the needs of modern students and instructors, this book covers the basic guidelines and principles of quality assurance as they relate specifically to drug design, development, and evaluation. You'll learn about the latest developments in the industry and how to apply these principles to the real-world challenges that you're likely to encounter. Whether you're a seasoned pharmaceutical professional or just starting out, you'll find this book to be an invaluable resource that you'll refer to time and time again.
Contents:
1. Introduction to Quality Management System
2. Good Manufacturing Practice Regulations- A Brief Scenario
3. Pharmaceutical Quality System-An Overview to ICH Q10 Guidelines
4. Analysis of Corrective and Preventive Action
5. Assuring Pharmaceutical Quality-A Brief Analysis of SOP's
6. Quality Defects-Achieving Zero Defects Policy
7. Handling of Market Complaints and Recalls, Review of FDA-483 Form
8. Pharmaceutical Quality Audits
9. USFDA Guidelines-Process Validation
10. Drug approval Process in India
11. Regulatory Requirements for Dossier Filing in ROW and International Markets