FDA Quality Metrics Program Aims to Share Quantitative Data With Global Regulators

The goal of the FDA’s quality metrics program is to share quantitative data with global regulators about the state of manufacturing quality, CDER Director Janet Woodcock said.

The FDA has received numerous disgruntled comments from industry on the quality metrics guidance released in August, “but I refuse to accept the fact that we can’t measure the quality of pharmaceutical manufacturing operations,” she said during the Parenteral Drug Association annual conference in Washington, D.C.

The quality metrics guidance identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers would collect and submit to the agency for each product they produce. That data would then be used to decide how often firms are inspected.

During an FDA public meeting last month, industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance.

Common Language Needed

“We may not have landed on the exact right measures,” Woodcock said, but if industry and the agency arrive at some consensus measures, then a common vocabulary could be developed that could lead to a globally harmonized approach.

Today’s practice of firms being inspected numerous times by different regulators is a “recipe for disaster,” she said.

The FDA currently shares information with international regulators through the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, known as PIC/S, but that information is in narrative form, Woodcock said. What is needed are “well-established, internationally recognized quantitative measures so we are all talking the same language … and that is a number,” she said.

To get there, GMP standards would need to be reduced to “hard, bright lines” that narrow the universe down to a more rational system, she said.

Based on the metrics companies provide, the FDA would give feedback on where they fell on the quality curve. That data — or “dashboard” — would not be shared with industry, but would be a tool for continual improvement.

Currently, field inspectors have a list that ranks companies according to their compliance history, and the quality metrics would be fed into that database to help the agency decide how often companies should be inspected.

The FDA’s new inspection protocol program would be further standardized to improve communication about the state of control in a given facility.

“In the future, we would like to have real-time discussions with inspectors in the field,” she said, where problems could be followed up immediately.

Woodcock acknowledged that the FDA’s quality metrics program will take years to implement, because companies are using different metrics and it will take time to figure out which are most reliable.

“The real frontier is international,” Woodcook said, where she envisions harmonized standards used around the world.

She acknowledged that little is known about the state of quality of many of the facilities importing drugs into the United States. To fix that, the FDA is also developing a global inventory of facilities that will include inspectional data.

The FDA released guidance in July in an effort toward improving compliance and inspection practices. Order our webinar FDA’s Draft Guidance – Request for Quality Metrics. Industry expert Andrew Harrison provides an overview of the guidance along with details on the specific quality metrics being requested.