Industrywide Quality Metrics Program Comes With Hefty Price Tag, ISPE Says
If the FDA were to implement a quality metrics program similar to the collection of 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says.
When you factor in what the FDA may require for official submissions — such as more thorough and complete data collection, additional review and data verification at different levels and disciplines, new or modified IT systems, data from throughout the full product supply chain and time for internal discussion, management review and above-site guidance — the estimate swells to more than $100 million.
The average time it took a site to collect annual data was 88 hours. This was true whether the site produced prescription brandname or generic drugs, OTC products, drug substances or was a laboratory.
Generics Took Longer to Collect Data
However, it took generics and OTC makers on average three times longer than originator sites to collect their data — 159 hours versus 54, the report says. Participants attributed the difference to an increased number of products and greater supply chain complexity.
OTC firms also spent more time than originators at the product level because they had to separate complaints down to individual formulations — such as different flavors or colors — rather than product family, and they had to disaggregate pack or unit data instead of cases, the report says.
The most time-consuming metrics to collect were OOS for final product and both critical and total complaints. Completing annual product quality reviews on time and recalls took the least amount of time, the report says. The most difficult metric to collect was recurring deviations rate.
Companies participating in phase one said they gained a deeper understanding of quality metrics definitions and design and were able to establish a centralized submission process. They also said they liked being able to examine their process against aggregated data from their peers.
ISPE released the report at the ISPE/FDA/PQRI Quality Manufacturing Conference in Washington, D.C. Phase two of the pilot program is set to kick off in July with a revised set of 13 quality metrics. — Kellen Owings
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