Quality assurance is the cornerstone of the pharmaceutical industry, ensuring that medicinal products are safe, effective, and of consistent quality. Pharmaceutical Quality Assurance integrates scientific principles, regulatory guidelines, and systematic management practices to control and improve quality throughout the product lifecycle. With growing global regulatory expectations and harmonization, a strong foundation in quality assurance is essential for pharmacy students and professionals.
The book “Pharmaceutical Quality Assurance (Theory)” is designed to provide a clear, structured, and comprehensive understanding of quality concepts relevant to pharmaceutical education and industry. The content is aligned with current academic syllabi and regulatory requirements and is presented in a simple, exam-oriented manner to aid effective learning. It covers key topics such as quality management systems, GMP, GLP, TQM, ICH guidelines, documentation, validation, calibration, analytical method validation, warehousing, complaints handling, recalls, and continuous improvement.
This book is authored by Dr. Anand Kumar, Mr. Pravat Ranjan Guru, Mr. Satya Ranjan Dalai, Dr. V. Amudhavalli, and Ms. Jayshree Vanshikumari Santosh Sharma, who have combined their academic expertise and practical insights to develop a student-friendly and reliable resource. The authors hope this book will serve as a valuable guide for undergraduate and postgraduate pharmacy students and as a useful reference for professionals involved in pharmaceutical quality systems. Suggestions for improvement are sincerely welcomed and will be considered for future editions.