FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together
Just over a year ago, the U.S. FDA released detailed information about the restructuring of the newly realigned Office of Regulatory
Affairs (ORA)
(1).
Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, provided an update on this and other ORA initiatives on Sept. 24 in the second plenary of the 2018 PDA/FDA Joint Regulatory Conference.
This realignment, coupled with the recent Mutual Reliance Agreement (MRA), is enabling ORA to refocus many of its efforts and reallocate resources, which is expected to impact the pharma industry.
The realignment of ORA inspections from a regional to a commodity focus has been welcomed by industry (2). Previously, FDA inspectors were region-based, inspecting different types of facilities. For example, an inspector might visit a parenteral manufacturing site one week and a food facility the next. Consequently, some inspectors may have lacked specific knowledge about the nature of the plants they were inspecting. With the commodity focus, pharma inspectors only inspect pharmaceutical sites.