Pharmabiz
 

Guidance on QA and QM in pharmaceutical industry

Our Bureau, MumbaiThursday, September 29, 2005, 08:00 Hrs  [IST]

Pharma Book Syndicate, Hyderabad, has published a book 'Quality Assurance and Quality Management in Pharmaceutical Industry'. Priced Rs. 695, this book is very useful as textbook for students of both graduate and post-graduate classes in Pharmacy, Analytical Chemistry and allied subjects. It shall serve as ready reference for scientific and management personnel working in various pharmaceutical industries for understanding the basic concepts and implementation of QA and QMS with latest guidelines. In recent times, advanced drug design, production processes and sophisticated analytical instrumentation have added new dimensions to the complexity of industrial pharmaceutical production process leading to the necessity of extensive and in depth implementation of Quality Assurance (QA) and Quality Management Systems (QMS). Further, new regulations and legislations concerning product quality requirements in pharmaceutical industry and proactive role played by regulatory agencies by way of enforcing legal penalties for nonconformity of quality standards have increased the responsibility of the manufacturer for the rigorous quality control of the product. In view of this, implementation of the Quality Assurance and Quality Management System concepts are playing a vital role in the production and global marketing in pharmaceutical industry. Thus, understanding of basic concepts and recent developments in QA and QMS has become very important both for scientific and management personnel and graduate and post-graduate students of Pharmacy, Industrial and Analytical Chemistry, Chemical Technology and other related disciplines who are likely to serve the manpower requirements of various pharmaceutical industries. This book authored by Prof. Y. Anjaneyulu, Director, IST, JNT University, Hyderabad, very senior Professor and reputed R&D Scientist and Dr. R. Marayya, a well-known pharma consultant gives the overall view of QA and QMS with reference to pharmaceutical industry. QMS, GLP, GMP, Statistical methods in quality control and quality audit are discussed very lucidly and with latest information and guidelines. The information presented in Chapter 4 on Methods of Analytical Quality Assurance is very useful as it provides many possible solutions for routine practice. In appendix, the latest information on the International Standards on QMS, GLP and GMP for pharmaceutical industry are included which will be very useful as a ready reference. Prof. (Dr.) Chandrakant Kokate, Former Vice-Chancellor, Kakatiya University, Former President, Pharmacy Council of India, Former E.C. Member & Chairman. All India Board of Pharmacy, A.I.C.T.E., congratulate Prof. Y. Anjaneyulu and his student Dr. R. Marayya for bringing out a textbook on this very important topic of great relevance in pharmaceutical field, in his review on this book For more details: Pharma Book Syndicate, 4-3-375, Ansuya Bhavan, Opp. Lane to Central Bank, Bank Street, Hyderabad - 500 095. Tel.: 040-23445666, 24755951 Email:info@pharmabooksyndicate.co, booksynd@hd2. dot.net.in

 
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