Quality Metric Requirements Coming Soon for Drugmakers

Within one to two years, the FDA plans to require drug manufacturers to submit quality metrics data, such as batch failure rates or complaint data, to the agency. It will, in turn, use the data to target its inspections.

One possible upside for manufacturers: better performing companies could face fewer inspections and faster regulatory approvals for certain applications.

The agency initiative, unveiled in March, is starting to come into focus, with an FDA official saying Sept. 27 that the goal is to collect quality metric data from manufacturers to improve post-market surveillance on quality. It will not, he says, result in a public rating system for consumers to use in judging companies.

“We don’t intend on publishing a restaurant-style scorecard,” said Russ Wesdyk, scientific coordinator in CDER’s Office of Strategic Programs and the current leader of the initiative.

Earlier this year, the agency called for comments on its drug shortages strategic plan, asking for insight on metrics that adequately monitor production quality. The FDA received 149 comments, gleaning many suggestions for quality metrics such as:

• Batch failure rates;

• Out-of-specification results;

• So-called “right-first-time” measurements, a quality management concept that focuses on defect prevention rather than defect detection;

• Customer complaint rates;

• Internal audit and regulatory agency inspection outcomes;

• Adherence and effectiveness of training programs; and

• The effectiveness of corrective and preventive actions.

The metrics would be used as part of the agency’s risk-based inspection program, which was mandated under the FDA Safety and Innovation Act passed last year. In the coming months, the agency plans to develop a list of quality metrics and determine the regulatory authority for collecting them from drugmakers and allowing for comment, said Wesdyk.

A manufacturer would be required to send in quality metrics data to the FDA, which would analyze it and determine the level of regulatory scrutiny for the company. Wesdyk said most companies do a good job and don’t want to be subject to the same regulatory scrutiny that poor-quality companies receive.

Another potential benefit is regulatory consideration. For example, if a low-risk site files a supplementary application for a low-risk product, there may be some “downstream regulatory flexibility,” Wesdyk said.

The FDA would use the metrics to easily identify problematic sites and work with those companies to hopefully avoid shortages caused by quality problems, he added. The metrics are expected to apply to various types of drugs such as OTCs and parenterals.

The agency will also use a suite of metrics to balance out any potential gaming of the system, he added.

For example, if the FDA were to use batch failure rate as a quality metric, a company could rework a batch about ten times to ensure it doesn’t fail, and thus record a low failure rate. However, if you combine that metric with right-first-time results, then “the batch failure rate would be low but right-first-time would be horrible,” Wesdyk said.

Manufacturers did have some concerns with the initiative, saying proper application of current good manufacturing practices should be enough to thwart shortages and stay in the agency’s good graces.

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