ABSTRACT
One of the most frustrating and time-consuming, not to mention costly, aspects of managing pharmaceutical and biotechnology production facilities is the investigation of environmental monitoring excursions. For purposes of this chapter, an excursion is defined as environmental monitoring data that fall at or above the action levels for the area in question. The regulatory agencies stipulate that environmental monitoring data should be trended, in order to better predict, and possibly prevent, the onset of an excursion. However, as most statisticians who have studied this subject know, in most areas, there are not significant data with which to predict such an occurrence. All too often, excursions appear seemingly out of nowhere. It is only upon closer examination of all operational aspects of the facility that a predictor of these excursions may be identified. All too often, these predictors have little to do with the environmental monitoring data, which was collected for trending purposes. These predictors are related to three key areas: facilities design, personnel management, and cleaning/sanitization programs. Problems with these areas cannot necessarily tell you when problems will occur, but it is almost assured that they will occur if these problems exist.
