OPQ Plans Team-Based Integrated Quality Assessments as Part of Drug Review Process

The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said last week.

Integrated quality assessments will be the central tenet of OPQ’s drug review process. An IQA team will consist of an application technical lead responsible for overseeing the scientific content of quality assessment and a regulatory business process manager responsible for process and the timeline.

Discipline-specific reviewers consisting of drug substance, drug product, process, facility, microbiology, biopharmaceuticals and Office of Regulatory Affairs investigators will be part of the team, as will — as-needed — members of the Office of Testing and Research, said OPQ’s Giuseppe Randazzo, acting director of the Office of Program and Regulatory Operations.

The number of experts needed to review each application will vary, depending on the potential risk of the product, he added.

OPQ will be continuously improving the single review template and new templates will be rolled out periodically. Agency IT improvements are expected to ease the review process and spur collaboration, Randazzo said. The new integrated process is expected to result in more predictable communication, with regularly scheduled team meetings. — Kellen Owings