ABSTRACT
The pharmaceutical industry’s understanding of how to validate nonaseptic manufacturing processes for drug products and for drug substances matured considerably between 1983 and 1987. The steepest part of the learning curve occurred during the time in which everyone involved was learning to speak the same validation language. Basic concepts came into focus when terminology describing those concepts crystallized and was assigned unambiguous definitions. Most controversies surrounding the basic concepts had dissolved by 1988. The few that lingered beyond that time, however, are worth addressing because they may help explain why compliance failures by some firms with regard to process validation continue to be of concern to FDA.
