About the Book:

Dive into the intricate world of pharmaceutical quality systems with "Regulatory Aspects of Pharmaceutical Quality System – Brief Introduction." Catering to the inquisitive minds of B. Pharm and M. Pharm students, this book offers a succinct yet comprehensive exploration of the regulatory landscape governing drug design, development, and evaluation. Unlike other textbooks on quality assurance, this gem delves deep into the fundamental guidelines and principles crucial for understanding the industry's latest advancements. Through its unified and practical approach, readers will not only grasp the essence of quality assurance but also learn how to navigate real-world challenges with finesse. Whether you're a seasoned pharmaceutical professional or a novice embarking on your career, this invaluable resource promises to enlighten, inspire, and become a treasured companion on your journey to mastering pharmaceutical quality systems.

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

About the Author: