ABSTRACT
One of the current trends in pharmaceutical facility construction is to stop the up ward spiral of technical facility requirements, where these requirements do little, if anything, to ensure product purity. Standards have often been established in the name of "GMP (Good Manufacturing Practice) compliance," without sound tech nical rationale; it is assumed that if "X" is acceptable to regulatory agencies, then "2X" must be better. In many cases, these requirements can lead to suboptimiza
tion (e.g., high utility operating costs for HVAC [heating, ventilation, and air-con ditioning] systems), or facilities in which productivity suffers (e.g., dedicated fa cilities or ones with poor material flow. In this chapter, we will discuss how facility designs can be driven by a scientifically based approach in order to pro vide facilities capable of reproducibly creating a pure product in an optimized manner, while achieving compliance with applicable regulations
Trends by their nature tend toward evolution, rather than revolution. Therefore, it is helpful to consider recent trends in facility requirements and the influence they have on what is happening now and into the future. One such major trend over the past several years has been a movement toward greater facility utiliza tion. There are far fewer facilities or pieces of equipment that today produce a sin gle product, except where volume so dictates, than were commonly encountered in the past. Multiproduct plants, which are flexible enough to provide a fast changeover between existing products or to accommodate new products, have become the norm for new facilities. Simultaneously, a greater focus, has been placed on ensuring the capability of "upstream" manufac turing facilities, such as bulk active synthesis plants, to reproducibly create a pure product.
