FDA Moves To Avoid Manufacturing Woes

Douglas Ellsworth, director of the US Food and Drug Administration division of manufacturing and product quality in the Center for Drug Evaluation and research office of Compliance, told the Nonprescription Drug manufacturers' Association that many FDA manufacturing initiatives are aimed at avoidance of problems. These include:

- spring publication of guidance on Good Manufacturing Practice for bulk drug chemicals. 80% of generic bulks, 70% of innovator firms' and probably most over-the-counter bulks come from abroad, so the FDA will hold international and domestic workshops to elicit comments;

- a statement on validation requirements for finished dosage forms. The FDA is still seeing changes in processes without validation, which have caused problems;