Voluntary Drug Quality Metrics Reporting Begins 2018
[This report has been updated to remove incorrect attribution.] Starting early next year, FDA will begin encouraging a voluntary quality metrics reporting program to calculate three metrics, CDER Office of Surveillance acting director Sarah Pope Miksinski told a Drug Information Association (DIA) session in Chicago 6/21. Late last year, the agency published a draft guidance, Submission of Quality Metrics Data, that explains the upcoming reporting phase, Miksonski said. The document says that CBER and CDER will use submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement in drug manufacturing. Eventually, rulemaking will be undertake to make such reporting mandatory.
In the voluntary reporting phase, FDA expects to learn more about a limited set of quality metrics and associated analytics, and how to improve the quality metrics reporting program, according to Miksinski. The agency expects that the large majority of voluntary reports will come from establishments engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms of “covered drug products” or active pharmaceutical ingredients used in the manufacture of such products.
Under the program, FDA hopes to work with establishments toward early resolution of potential quality problems and to reduce the likelihood that the establishment’s operations will be disrupted and impact the drug supply. The quality metrics will also help guide inspection planning and should encourage lifecycle manufacturing improvement, Miksinski told DIA.
Voluntary reporting will initially focus on 3 metrics:
Lot Acceptance Rate — an indicator of manufacturing process performance. The rate is the the number of accepted lots in a timeframe divided by the number of lots started by the same covered establishment in the current reporting timeframe.
Invalidated Out-of-Specification (OOS) Rate — an indicator of a laboratory’s operation. The rate is the number of OOS test results for lot release and long-term stability testing invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results in the current reporting timeframe.
Product Quality Complaint Rate — an indicator of patient or customer feedback. The rate is the number of product quality complaints received for the product divided by the total number of dosage units distributed in the current reporting timeframe.
Miksinski noted that the metrics can be reported either by site or by product, with product reports being the FDA preferred method. “A product reporting establishment will submit a single product report that includes data from all facilities involved with the manufacture and testing of that product,” she said.
Additionally, Miksinski said FDA will publicly publish a list of names of establishments that voluntarily report all or a subset of quality data. “The list will provide information about whether an establishment voluntarily submitted quality metrics data to the agency, and if so how much data was submitted,” she said. “It should be noted that inclusion on the list is not an indication of FDA’s evaluation of the submitted data. The reporting is proposed to be a tiered approach (Top/Middle/Bottom), with only companies achieving the top tier if they report complete data supporting all metrics included for EACH covered establishment in the manufacturing supply chain for all covered drug products (or APIs used in the manufacture of a covered drug product) for the full year reporting period.”