FDA, Suppliers, & Process Changes

By Wayne Koberstein, contributing editor

Most of the questions posed in this article might well be addressed to an expert. But the actual function of the article is to arbitrate already well-known expert opinions rather than add to them. The two best-known bodies of opinion on this month’s topic represent the perennial dichotomy between industry and FDA supporters.

If you subscribe to the view that the FDA is an ever-more opaque miasma of bureaucratic obstruction, you may be in the industry camp that believes process changes in drug manufacturing should be left to the plant engineers. From the agency’s perspective, however, the current procedures for validation of process changes simplify regulation and make it more transparent — precisely by giving you and your suppliers responsibility for deciding when a particular change in process is sufficiently significant to trigger FDA involvement. If any cooperation among all three parties is going to take place, its success will hang on that decision.