The FDA's new initiative on drug product quality
We all read with interest the announcement in the summer of the FDA's intention to review its approach to drug product quality. The first inklings of the way in which FDA intends to go about this process are now emerging.
We all read with interest the announcement in the summer of the FDA's intention to review its approach to drug product quality. The first inklings of the way in which FDA intends to go about this process are now emerging.
Initial public statements suggest that FDA is not looking just at current Good Manufacturing Practices (cGMPs) but is taking a wider look at the question of product quality. Together with resource implications that all similar agencies have to face, it seems to be considering the most effective use of that resource.
According to reports, immediate steps in the next six months or so will revolve around scientific workshops with stakeholders, enhancement of scientific and technical expertise, encouragement of greater use of comparability protocols and an increased use of product specialists in inspections. This will be coupled with alterations in the work planning process together with a move to the risk-based approach.
Further out, it seems there will be a move to external review and benchmarking, while inspection programmes will also be more integrated to submission review. In addition, the adoption of new technologies by industry will be encouraged.
Taken individually, all of these concepts have merit. The challenge is to integrate them into, or use them to improve, the current system in a way that benefits all stakeholders.
The UK industry's initial reaction to the FDA's thinking has been positive. We will certainly be willing to engage in the fullest way possible in helping facilitate any dialogue that puts GMP inspection on a sounder scientific basis.