US FDA Seeks Help in Selecting High-Risk Manufacturing Facilities for Inspections
Now the FDA (Food and Drug Administration) is taking its austerity goals one step further as it seeks a consultant to help in its risk-based analysis for selecting facilities to support the various types of inspections the agency conducts.
Within 18 months of selecting a consultant, the FDA seeks a system that will allow for interoperable data exchange between manufacturers and the agency, as well as one that can select and import quality risk indicators from various internal, external and unstructured data sources including an internal data warehouse, such as the Oracle Business Intelligence Enterprise Edition, for risk evaluation.
The FDA is trying to think about what tools it can use to assess manufacturing best practices as opposed to just creating best practice guidance documents, Cameron Tew, executive director of research and advisory services at Best Practices, LLC, told us. Best Practices applied for a similar proposal late last year but did not win the contract.
In terms of the type of contractor the FDA is seeking, the agency says it wants expertise in advanced statistical methods, risk analysis, operations research, trends analysis, modeling and simulation, and other relevant mathematical or engineering methods. Such a consultant, according to the FDA, should be able to configure and implement a quantitatively-scaled, multi-attribute, risk management commercial-off-the-shelf solution that will support risk-based prioritizations for facilities and sites related to the following inspection types:
• Good Clinical Practice;
• Bioequivalence;
• Good Laboratory Practice;
• Institutional Review Boards;
• Radiological drug review committees;
• Risk Evaluation and Mitigation Strategies;
• Post-marketing adverse drug events;
• Post-marketing requirements;
• Good Manufacturing Practice;
• Pre-approval; and
• Post-approval.
Interested parties should respond to the request by Friday at fureel.fbybqxbin@sqn.uuf.tbi.
