The recent Bio/Pharmaceutical Outsourcing Report article, FDA Increases Vigilance on Aseptic Processing Facilities does a good job describing the latest changes in the way the FDA is inspecting facilities. This quote referenced in the article sums up the increase in enforcement activity – “Several years ago, FDA hired a large number of new employees and put many of those employees in the field offices. As a result, there are more inspections today than a year ago, more inspectional observations, and more enforcement actions growing out of those inspections.”
In my personal interaction with professionals in GMP compliant facilities there is a keen awareness that the FDA is stepping it up and most of these companies are being proactive in ensuring their Quality Systems are up to the standard.
Thanks go out to Barry Freidman and PharmaSource for publishing this excellent article.