FDA to Fund Research on Further Use of Quality Metrics

The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards.

The proposed projects will evaluate batch-to-batch and unit-to-unit variability of companies’ products, capturing data on such quality chemical and physical attributes as tablet weight, assay, content uniformity and dissolution.

The data will be used to create a risk-based lifecycle approach that measures quality over every step of the manufacturing process, says Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

CDER plans to use the information to develop data-based guidance on the use of statistical tools and standards to improve drug quality.

Grantees should look at factors such as the range of product dosage forms, manufacturing complexity, types of manufacturing, inter- and intra-batch variability and analytical method variability. The goal is to be able to statistically characterize manufacturing variability, whether across the entire pharmaceutical industry or defined by subsets identified through analysis, the FDA says.

Down the line, collected variability data could be used for bioequivalence testing, Pitts says. It also could be used by OPQ to help support quality-based inspections.

The agency will award $200,000 per recipient in fiscal year 2015, with additional allotments of $200,000 possible over the next two years.

Applications are due July 7, and the FDA encourages applicants to apply early to allow time for any corrections.

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