ABSTRACT

INTRODUCTION The need to meet the current Good Manufacturing Practices (cGMP) regulations is paramount in the pharmaceutical industry. Facilities that effectively incorporate the GMP requirements are easily licensed and thus bring the project on stream in a timely fashion. The incorporation of the GMP requirements into Good Design Practices (GDP) at the onset of the project ensures that this aspect of regulatory requirements is met. Facility designs that do not adequately or that poorly address cGMP requirements, face more regulatory scrutiny and possibly will not be licensed without significant changes.