Globally, a wide number of ideas, principles, rules, and practices have been produced by organisations and governmental authorities that care about quality. Guidelines and restrictions were supplied by local and international drug regulatory agencies to ensure high-quality goods. Quality assurance and quality management, which deal with the procedures to be used in the pharmaceutical sector to generate high-quality goods, have developed into a specific field of study in this context. Therefore, an important first step in achieving the required quality goods is to understand the many various facets of QA.
Keeping in view the requirements of students and teachers, this book has been written to cover all the topics in an easy-to-comprehend manner within desired limits of the prescribed syllabus, and it provides the students concepts of quality assurance and quality management, TQM, QbD, ICH guidelines, ISO 9000 and 14000, etc. which are required by them during their pharmaceutical career.
This textbook contains the whole PCI-mandated syllabus for the topic of pharmaceutical quality assurance in B Pharm programmes and covers all areas of pharmaceutical quality assurance required for an industrial pharmacist. The key assets of the book include:
• The book gives readers a thorough understanding of the many facts of pharmaceutical quality assurance in accordance with industry demands.
• For UG students, the book covers the whole syllabus outlined by the Pharmacy Council of India, New Delhi.
• The material is provided in a way that Pharmacy UG students may comprehend simply and logically.
• Included are the most recent updates to the rules and regulations governing supply, production, and development. As a result, the book offers the most recent information available.
