FDA plans to overhaul its GMP inspection rules

The US FDA is updating inspection rules for pharmaceutical products in an effort to improve the safety and efficiency of production and restore consumer and manufacturer confidence in the agency.

The planned revision of the current 'Good Manufacturing Practice Program' comes in the wake of several recent incidents that have shaken confidence in drugs manufacture in the US. They include the recall by a US tissue bank of soft tissue grafts that may have been contaminated, agreement by Schering-Plough to a US$500m (£328m) fine for quality-control violations and an admission by Eli Lilly that factory problems could delay as many as five drugs under review.

The FDA said the proposed changes would improve its inspection of medical factories and permit drugs makers to better employ new technology that could improve quality. The agency may try to convince American companies to emulate their European counterparts by using automated manufacturing systems to monitor different steps with sensors.

A challenge facing the FDA may be in financing the proposed changes. The US Congress has not increased financing for regular inspections, despite an increase in the number of drugs the federal agency oversees. Last year, the agency inspected 1,600 factories for compliance with manufacturing standards, down from 4,300 in 1980.

The FDA hopes to accomplish three main goals with its revisions:

• provide additional regulatory attention and agency resources on those aspects of manufacturing that pose the greatest potential risk;

• establish and enforce pharmaceutical product quality standards while not impeding innovation in the pharmaceutical industry;

• improve consistency and predictability among FDA member agencies.

The agency expects its goals to be fully implemented within two years.