Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP re…
An examination of US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. It recommends pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.
Contamination in pharmaceutical manufacturing poses significant health risks, yet it is not fully addressed in existing compendia. This book provides for the first time a one-stop reference on the subject. It surveys the sources of contamination, explaining how to identify conta…