FDA has put in place an umbrella “Concept of Operations” (ConOps) intended to support the Office of Pharmaceutical Quality (OPQ) in its efforts to ensure consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications and create a more cohesive review/inspection process.
During the summer, FDA released a ConOps white paper spelling out how CDER and the Office of Regulatory Affairs (ORA) “will work in a vertically-integrated, programmatically-aligned environment regarding application review and inspections, and the compliance activities associated with them.”
The ConOps directive establishes an operating model for pre-approval, post-approval, surveillance, and for-cause inspections – detailing the process by which the inspection strategy will be planned, how the inspection will be conducted, and how the findings will be communicated. Included are flow diagrams for the various inspection types, and a description of the roles and responsibilities for the Integrated Quality Assessment (IQA) process.
The paper was followed by a Q&A explaining further how ConOps will support the agency’s Program Alignment initiative (see IPQ December 27, 2014) and its user fee commitments – for example, regarding the new 90-day deadline on making inspection classification decisions and on domestic/foreign inspection parity.
At the end of August, FDA Commissioner Scott Gottlieb posted an FDA blog further highlighting the background and motivation for ConOps and its significance to the agency’s drug regulatory process.
At the opening plenary session of the ISPE/FDA/PQRI Quality Manufacturing Conference held in Arlington, Virginia in June, OPQ Director Michael Kopcha provided a “progress update” on his office. He explained how the operations directive was needed to integrate CDER and OPQ with the new ORA organizational structure, which he noted, was the first major overhaul of the field organization in several decades.
Having this OPQ/compliance office/inspectorate ConOps in place up front will make the interactions smoother and more uniform and help achieve the “one quality voice” that OPQ was set up to accomplish, Kopcha affirmed.