chapter  2
10 Pages

Containment and Good Manufacturing Practices

WithMelvin J. Crichton

The International Society of Pharmaceutical Engineering (ISPE) Baseline Facility Guides are being developed to help facility designers gain a more common understanding of current Good Manufacturing Practice (GMP) expectations, while applying good engineering practices to achieve optimal utilization of capital. The ISPE Baseline Guide program encompasses ten guides, two of them will be “horizontal” and guides that cover all types of facilities: Water and Steam Systems and Commissioning and Qualification. In a bulk pharmaceutical chemicals manufacturing facility, costs associated with open processes are driven not only by GMPs, but also by environmental, insurance, worker protection, and energy issues. The Sterile Manufacturing Facilities Guide required the largest amount of writing effort to date. In sterile product manufacture, the product may be processed aseptically, requiring the process to be performed in increasingly clean environments.