ABSTRACT
A chemical reaction process, the large-scale conversion of raw materials to an intermediate or product, is considered validated if it can be shown to consistently produce material of defined quality following a set of manufacturing instructions. Attaining this knowledge and performance is highly dependent on acqui ring a quantitative understanding of all critical factors that influence the process. The Food and Drug Administration (FDA) is developing ways to positively reinforce this concept. In the future, companies will benefit from a lower regulatory burden for process validation and improvement if their commercial manufacturing process can be shown to be well understood. In particular, a change control procedure would be sufficient to manage process improvements without submission of additional data to the FDA (1).
