Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Ryan E. Day
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
Taran March @ Quality Digest
From digital submissions to integrated document control, the agency moves into the lean arena
Dirk Dusharme @ Quality Digest
By scaring off small medical-device companies, Canada could limit number of important and innovative products
Mike Richman
For answers to some troubling life-science questions, ask a quality professional
Ryan E. Day
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA

More Features

FDA Compliance News
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live
Awards help states implement multiyear produce-safety systems

More News

Michael Causey

FDA Compliance

Quality Takes Time, FDA’s CDER Reminds Drug Makers

Lessening the workload is proving to diminish waste

Published: Wednesday, February 4, 2015 - 12:21

Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the 5th century B.C. and the 16th century A.D. The Great Pyramid of Giza took about 20 years to construct, according to ancient historians, but it must be remembered that Egypt’s rulers were pretty rough on their nonvolunteer workforce. Deadlines had a deeper meaning back then.

By contrast, the Center for Drug Evaluation and Research (CDER) Quality Initiative has been with us some 10 years or about the time it took the United States to finish constructing the Panama Canal. Both projects have had to dig through—and around—a lot of muck. At the peak of work, excavators in Panama carved out the equivalent of the English Channel Tunnel every 14 weeks. It’s not fair to hold the agency to that same standard.

Instead, let’s acknowledge that the Food and Drug Administration (FDA) just completed its own new structure called the Office of Pharmaceutical Quality (OPQ). Less bricks and mortar than a shift in human capital, the OPQ will take on some of the functions and staff at the Office of Pharmaceutical Science (OPS). The OPQ will also take some preapproval and surveillance inspections duties from the Office of Compliance (OC), and absorb some of the inspection-related activities for bioequivalence/bioavailability and nonclinical studies from the OC’s Office of Scientific Investigations. The idea is to make the drug review more integrated with the FDA and improve communications.

The FDA hopes the OPQ will streamline the processes that monitor drug quality throughout the product life cycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

The OPQ was built, in part, in response to the falling number of drug-related product recalls over the past few years. The FDA believes the OPQ will help it better organize and quantify the state of manufacturing at drug facilities in the United States and abroad.The FDA has recently been pushing a new approach to quality metrics, as highlighted by the CDER’s Russell Wesdyk. His presentation outlines the CDER’s revised way of looking at surveillance and adoption of quality metrics that promote the use of a common language to improve measurement.

According to Wesdyk, quality metrics will be used to assist segment sites and producers based on risk when it comes to inspection and reviews. But it won’t issue “restaurant style grades” reporting how one facility stacks up against industry groupings. Wesdyk encourages any interested parties to reach out to him as the FDA’s thinking evolves. That’s a good thing.

Remember, it’s not as if the Panama Canal doesn’t require some maintenance now and then. The FDA’s got the right idea here.

The alternative is to build something and then forget about it. We’ve all seen how that usually turns out. Take a look at the Pyramid of Giza lately?

First published Jan. 21, 2015, on the AssurX blog.

Discuss

About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.