Pharmaceutical Quality Assurance and Management

by K. P. Bhusari (Author), U. D. Shivhare (Author)

The global market associated with pharmaceuticals has progressed enormously since last few decades. The quality and economy of a pharmaceutical product became an essential aspect for its existence and fulfillment of global requirements. It is also a concern for various regulatory agencies all over the world. Pharmaceutical manufacturer has to produce the products that meet the prescribed standards of certain international regulatory agencies and local government. These agencies provide guidelines and set various regulations for the pharmaceutical manufacturers to get quality products. In concern with all these facts, ‘quality assurance’ and ‘quality management’ became a specialized area of study that deals with the practices to be adopted during the manufacturing of pharmaceuticals. This book deals with all the elements of quality assurance and management.
Salient Features:

• Presented the information in condensed and cohesive form
• Covers different validation protocols for various processes, methods and equipments involved in the manufacturing
• Involved pharmaceutical inspections, various regulatory acts

Explained the quality management system and its role