Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time.
By December 12, 2011, FDA expects that all producers of PET drugs in commercial clinical use will have submitted applications for marketing approval. Manufacturing facilities are expected to be inspection-ready at the time of filing as inspections will follow soon after.
As these regulations are only recently enacted, most of the estimated 150 manufacturers of PET drugs have never been inspected by FDA. To date, only four PET drugs have been approved.
FDA held a public meeting in early March at its White Oak campus to discuss the implications of the new rules on PET drug registration, listing, and inspection. The discussions have relevance for the other similarly high-tech products now emerging onto the agency’s radar screen.
To help educate the audience on the inspection expectations, Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) Team Leader Brian Hasselbalch provided an overview of the nuts and bolts of the agency’s inspection process, and OC investigator Frank Perrella shared observations from recent PET drug manufacturing inspections.
Perrella noted that the inspection observations he was sharing were those that have been seen “repeatedly” in PET drug inspections. “We would like to see some changes in some of these areas,” he emphasized.
[More on FDA expectations for PET drug inspections is provided for subscribers here. Also see the IPQ “In the News” companion story for more on the discussions at the FDA workshop regarding the application process for PET drugs. Nonsubscribers may purchase the stories for $95 each by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here].
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