The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits

Industry Identifies Top 10 Quality Metrics for FDA

Dec. 20, 2013

A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program.

Working with agency guidance, the group of more than 300 drugmaker quality representatives winnowed a list of 40 potential metrics down to the ten recommended items. For items to be tracked for each product, the group chose:

  • Confirmed product quality complaint rate;

  • Confirmed out-of-specification (OOS) or laboratory failure rate for a product;

  • Process capability by product;

  • Critical investigation rate of the product; and

  • Batch rejection rate.

The group did the same exercise for metrics to be reported on a manufacturing site-wide basis, choosing:

  • Effectiveness of the corrective and preventative action system;

  • Critical investigation rate by site;

  • Batch failure rates for the site;

  • Confirmed OOS rates by site; and

  • Number of investigation-free lots.

The industry representatives, who gathered at an FDA-PDA workshop in Bethesda, Md., earlier this month, also favored examining quality metrics data for trends by reporting data each quarter for a year. They suggested the FDA track no more than four metrics at a time.

FDA officials have said they will soon compile a list of metrics and distribute it for public comment, with plans to start collecting metrics within two years.

While industry representatives believe these metrics are important, collecting data on them could be a challenge, some say. Some industry representatives said certain metrics had vague definitions that need to be clarified. For instance, a metric of “confirmed” product complaints would need to detail what “confirmed” means.

Some companies wait to confirm a complaint when they get a sample back and test it. Others, however, confirm all product complaints, said Glenn Wright, senior director of project management technical services/manufacturing sciences for Eli Lilly.

Other representatives questioned the definitions for “effectiveness” and “critical.”

Industry doesn’t need to reinvent the wheel when it comes to some definitions, said Carmelo Rosa, supervisory consumer safety officer for CDER. The FDA and the International Council on Harmonisation have definitions on various terms that can be used for the metrics program, he noted.

One potential burden is aligning existing company metrics to whatever the agency decides to collect, which conference attendees said could be costly if it requires companies to overhaul their existing metric processes.

FDA officials assured attendees the agency would consult with industry as it implements the quality metric monitoring, with the eventual goal of fewer inspections for high-quality companies. CDER Director Janet Woodcock closed the conference by saying that the agency doesn’t plan to collect data on more than 16 metrics. Woodcock said she hopes within three to five years, the agency can publish the state of pharmaceutical quality industry-wide based on quality metrics.

Get your quality metrics right and you’re one step closer to acing that FDA inspection. Investigations Operations Manual 2013 fills in step two: keeping you up-to-date on inspection standards and protocol. Order your copy now.