chapter  5
16 Pages

REGULATORY ISSUES: AN AMERICAN PERSPECTIVE

The U.S. Food and Drug Administration (FDA) recognizes that the technology associated with the manufacture and control of lyophilized dosage forms is complex. Their expectations for the manufacturing process of a commercial product can, however, be stated very simply. They believe that the process should be well defined, validated, and controlled. For example, the development work for the lyophilization cycle should be completed before the final process is written, appro­ priate process controls should be in place, and the process should be validated to demonstrate that it repeatedly achieves its desired results. The FDA also understands that there are many complicated factors in­ volved in the task of successfully lyophilizing a pharmaceutical prod­ uct; so in July 1993 they issued a Guide to Inspections of Lyophilization of Parenterals to provide guidance and information to investigators about industry procedures, and to discuss selected inspectional concerns as­ sociated with lyophilized products. The information in this chapter is derived mainly from the Guide and published observations from re­ cent FDA inspections.