The QMN Weekly Bulletin

FDA Plans to Emphasize Metrics, Not Documentation, in Inspections

Nov. 15, 2013

The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics.

“We really want to know more about the results,” not the design, of a facility’s quality system, CDER Director Janet Woodcock said Nov. 4.

The agency plans to require drug manufacturers to submit data about specific quality metrics within a year or two; it is still deciding what metrics to require, although officials have floated metrics such as batch failure rates or complaint data.

Woodcock, speaking at the 2013 annual meeting of the International Society for Pharmaceutical Engineering (ISPE) in Washington, D.C., said the FDA wants to find metrics that would be appropriate and simple. ISPE is currently conducting a project to solicit feedback from industry on objective and useful metrics. The goal is to develop a white paper that is acceptable to industry and regulators that defines the best metrics for use in a risk-based inspection program.

Woodcock said that many companies already belong to quality organizations such as Six Sigma, and use measures that assess how well they are doing. However, some companies have complained that such measures and metrics are “internal tools” that would be too burdensome for them to report and cause confusion in the marketplace.

The push for quality metrics is tied to legislative mandates in the FDA Safety and Innovation Act to conduct more risk-based inspections. The FDA doesn’t plan to publish quality scores for individual companies, said Woodcock. The goal is to publish “the state of quality of manufacturing in the pharmaceutical industry,” she said.

By publishing an overview of how the industry is doing as a whole, “individual companies can benchmark themselves against that,” Woodcock said.

She added that the agency is willing to consider a reward for companies with a good quality record. One such incentive could be more regulatory freedom to operate, Woodcock said, but she declined to elaborate on that concept.

The upside for drugmakers under the risk-based inspection regime is that better-performing companies would face fewer inspections.

The idea of financial incentives for companies that make manufacturing and product quality improvements was floated in a strategic plan to combat drug shortages unveiled last spring. The plan didn’t elaborate on what the incentives could be, and noted that the agency has a limited ability to offer such reward.

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