Risk-Managed GMP

This book analyzes Good Manufacturing Practice (GMP) in a systematic way, providing practical orientation on how to prepare products meeting their established specifications. The author uses his experience to review GMP following a risk-based approach. The different processes and associated elements that compose the supply chain are identified and examined by means of numerous tables and figures that facilitate comprehension and application.

Dr. Jordi Botet is a graduate in Biology and in Pharmacy and Ph.D. in Pharmacy who works as a consultant providing worldwide GMP guidance and training. He has been involved in pharmaceutical manufacturing, and since 1997 he has been cooperating in pharmaceutical projects, providing advice and training. Dr. J. Botet has written many papers and books on GMP and specialized pharmaceutical topics (utilities, premises, quality assurance, change control, risk management, validation, training, etc.). He can use several languages and this has allowed him to give many lectures and courses in different countries in Europe, America, Africa and Asia.