ABSTRACT
In the first edition of this book, Loftus [1] focused on the factors that justify the need for the documentation of process validation (PV). These factors included needs associated with current good manufacturing practice (CGMP), the concept of efficient manufacturing processes, the team approach to development and plant introductions, and the planning of activities involving the validation effort itself. The second edition [2] expanded this focus by looking at the ways in which process validation should be viewed as part of the continuum of technology transfer activity. This would include looking at the factors that will constitute the validation effort, carrying out the testing that will demonstrate the fact that the process is reproducible, and making PV an integral part of a total quality management (TQM) effort.
