ABSTRACT
INTRODUCTION The pharmaceutical industry has entered the twenty-first century, a new era that will be far
more scientific, technologic, and sophisticated than anyone would have imagined just a
quarter of a century ago when it was still a tradition to develop formulations and processes
mostly based on trial and error. The future success in all areas of pharmaceutical science will
depend entirely on how fast pharmaceutical scientists will adapt to the rapidly changing
technology. The regulatory agencies seem to enforce such changes as evidenced by the fact that
the goal of FDA’s recent Process Analytical Technology (PAT) initiative is basically to
understand and control the manufacturing process and to realize that quality cannot be tested into products but it should be built-in or should be by design.
