FDA has recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance, and at what frequency. In concert with the method revamp, the agency has introduced a multi-year resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.
Drug manufacturers spend a lot of time and money preparing for and hosting agency inspections. While both FDA and the U.K.’s MHRA use risk-based inspection planning, their processes and sources of information differ. Understanding how the agencies decide which firms to inspect and at what frequency will help inform audit preparation activities and allow better resource planning on the part of drug manufacturers. During this course, you will learn how your firm’s field alert reports, recalls, technologies, previous inspections by both US and EU agencies, and drug application information impact the frequency of agencies’ inspections.
In addition, you will review how companies can use similar information to find out how they compare with their competitors from a compliance and risk standpoint, and use that same information as a data-point for selecting contract manufacturing organizations (CMOs).
At the completion of this session, you will be able to:
- Understand the OPQ/OS reorganization and the impact of FDASIA on inspections
- Understand what information FDA and MHRA use to decide what companies to inspect
- Find similar information to use in selecting CMOs
- Understand the compliance escalation model used by MHRA and EMA