ISPE: Industrywide Quality Metrics Program Doable, but Costly

If the FDA were to implement a quality metrics program similar to the collection of the 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 or drug substances.

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.

Drug substance makers and laboratories needed significantly less time to collect data than finished product manufacturers — averaging just 45 hours — because there was less data to collect, the report says. The number of products a site produces did not seem to influence the collection and submission effort, ISPE says.

The data also show differences in the time it took to collect data at the product and site level. For instance, it took OTC makers 15 percent more time to collect data on three metrics — lot acceptance rate, confirmed out-of-specification rate and complaints — at the product level than at the site level. By contrast, originator firms were able to collect the metrics just as easily at both levels. This is because originator sites are more likely to already have systems in place to collect product-level data, according to ISPE.

The most time-consuming metrics to collect were OOS for final products and 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.

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