ABSTRACT
I. PROCESS MONITORING The environment of process monitoring in the pharmaceutical industry is processparametric, largely batch-operational, and dependent upon validation integrity. The parametric aspect compares the actual physical measurements at certain moments in the process to the specification under which the product was licensed to manufacture. A regulated industry is required to produce its product within those specifications, but this observation is only to establish a context, since the reader is probably most aware of those operating constraints. The batch-operational segment of process monitoring is a temporal measurement that regulates the genealogy, time, and transition that a material undergoes from state to state. In biologics, with live cells, the expression of proteins occurs within such a distinct time period and is optimal when this expression peak is not overshadowed by cell mortality, debris, and by-products. Validation integrity in the context of process monitoring has several important factors to consider. The integrity of any batch is dependent as much on the physical· resources as it is on the knowledge resources that contribute to the capture, analysis, and interpretation of process data. Validation integrity is a concept that focuses on the initiation and conservation of system validation. This section of the chapter will focus on this triangle relationship (Fig. 1).
