The QMN Weekly Bulletin
Pharmaceuticals / Quality

FDA Refines Quality Metrics Program Guidance

Dec. 2, 2016
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As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system.

In a revised draft guidance released Wednesday, the FDA makes changes to an earlier version by adopting the phase-in approach to quality metrics reporting, reducing the number of primary metrics collected, supporting both product and site reports, modifying quality metrics data definitions and clarifying examples for each definition. It also describes the process for submitting comments within a quality metrics data report.

The FDA’s pilot phase of the program will give drugmakers an “opportunity to demonstrate transparency and a willingness to proactively engage with the agency” to monitor quality controls and develop compliance as well as inspection policies, according the agency’s Federal Register notice. And while participation in the pilot is not mandatory, if only a few facilities participate, the FDA might not be able to use the data to help evaluate its planned analytics for the future mandatory program.

The revised draft guidance details the data points drugmakers may report for the voluntary program, providing three overarching areas of data collection — lot acceptance rate, invalidated out-of-specification rates and product quality complaint rates — that build on the 10 points outlined in an earlier draft guidance and give further criteria for each. The chart below includes a full list of the 11 data points the FDA will accept for the pilot program.

Lot Acceptance Rate Data:

  • The number of saleable lots started which are intended for primary packaging or distribution.
  • The number of saleable lots released for primary packaging or distribution.
  • The number of saleable lots started which are intended for primary packaging or distribution and were rejected.
  • The number of lots started of in-process and packaging product lots which are intended for distributed product.
  • The number of in-process and packaging product lots released which are intended for distributed product.
  • The number of in-process and packaging product lots which were intended for distributed product and were rejected.

*Examples of saleable lots include bulk tablets, filled vials, bulk milled in-process material if manufacturing is performed at a listed establishment, the FDA said.

Invalidated Out-of-Specification Rate Data:

  • The number of lot release test OOS and long-term stability OOS results for the finished drug product or API where the long-term stability test supports the labeled expiration date.
  • The total number of lot release and long-term stability tests conducted for the finished drug product or API where the long-term stability test supports the labeled expiration date.
  • The number of OOS results for lot release tests and long-term stability tests for the finished drug product or API where the source of the OOS result is identified as an aberration of the measurement process and where the stability test supports the labeled expiration date.

* Examples of counted OOS results that should be counted include both finished drug product and API and long-term stability test results and all finished drug product and API and long-term stability test results that initially indicate OOS, the FDA said.

Product Quality Complaint Rates:

  • The number of product quality complaints received for each product. 
  • The total number of dosage units distributed for each product.

*Examples of product quality complaints do not include multiple counting of the same product quality complaint if the complaint receiver forwards the complaint to individual manufacturers for further investigation or all potential quality issues, such as sub-potency, the FDA said.

These three areas also represent the quality metrics the FDA intends to calculate from the more than a dozen data points drugmakers can submit during the pilot program. Previously, the FDA planned to calculate four quality metrics and proposed three optional measures. The number of annual product reviews completed for each product is no longer a data point listed for collection.

During the voluntary period, the FDA will publish a list of establishments that submitted data. These establishments will receive rankings based on the completeness of their product reports. For example, companies submitting reports that identify all covered facilities in the manufacturing supply chain for all covered drug products, but omit quality metrics data will be designated “product supply chain reporters” — the lowest tier on the rankings.

The quality reports should be submitted on a quarterly basis throughout the year for the FDA to prepare its tiered reporters list, according to the revised guidance.

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