New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum

The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts.

In addition to the inspection data it has compiled, other information made available to the agency under the 2012 FDA Safety and Innovation Act (FDASIA) – such as unique facility identifiers, more information on excipients, and agreements for sharing information with other regulators – will enhance CDER’s ability to target inspections based on risk and perform them more efficiently (IPQ January 23, 2014).

Related efforts within the recently-formed Office of Pharmaceutical Quality (OPQ) Office of Surveillance (OS) are aimed at an “all-source” approach to product and facility information gathering for all CDER-regulated products, and the development of inspection protocols designed to better target and utilize the information collected during facility inspections and from other sources (IPQ November 10, 2014).

At a Great Lakes cGMP and Regulatory Science Forum at the University of Illinois at Chicago in late-September, FDA Chicago Office Director of Investigations Ricki Chase discussed the upcoming compliance program revision for biotech products and the risk factors that are used to prioritize facility inspections.

In discussing the risk-based model, Chase highlighted the factors that are prominent on the investigators’ radar screens for biotech product inspections as well as the key concerns with injectable products and metered dose inhalers.  She also reviewed some of the important issues that FDA is seeing reflected in complaints and recalls that will get investigator attention.

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