The purpose of this book is to introduce pharmacy students to the fundamentals of principles, practices and technologies involved in pharmaceutical quality assurance and its exploration from laboratory to global market. An integrated presentation is used in this textbook to demonstrate the interrelationships between various aspects of phartmaceutical quality assurance. An extensive overview of cGMP, QC tests, documentation, quality certifications and regulatory affairs is potentially presented in this book.
Each chapter of this book is written at a level consistent with the requirements of students being introduced to this area of study. Because this textbook often is used early in the professional curriculum, it contains important introductory topics, such as Quality Assurance and Quality Management concepts, Organization and personnel, Quality control, complaints and document maintenance and calibration and validation. Chapters are designed to provide opportunities for creative thought and application of the content.
The objective upon completion of the subject, student shall be able to:
1. understand the cGMP aspects in a pharmaceutical industry
2. appreciate the importance of documentation
3. understand the scope of quality certifications applicable to pharmaceutical industries
4. understand the responsibilities of QA and QC departments.
This book will also useful to all those students seeking to explore their carrier in pharmaceutical industries.
This book covers all the content which has prescribed by Pharmacy Council of India in New Syllabus All over India.
Contents –
1. Quality Assurance and Quality Management
2. Organization and Personnel
3. Quality Control and GLP
4. Complaints
5. Calibration and Validation
