A Text Book Of PHARMACEUTICAL QUALITY ASSURANCE

Résumé du livre

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.