Reducing Human Error In Gmp Pharma/Biopharma Operations

By Harry Benson

In the pharmaceutical and biotech industries, delays in getting products to market cost companies revenue and inhibit patient access to their medications. CAI clients often seek help in closing open investigations, but ignore the source of these investigations, even while product sits quarantined. Where clients really need help is in cutting human error off at the source. Industry average deviation costs generally range from $25,000 to $55,000, yet they can top $1,000,000 per deviation if product loss is involved. Investigating one deviation alone can cost a company thousands of dollars. When considering the cost of heroic efforts to produce and release batches, subsequent employee turnover, and potential downtime, cost increases exponentially.

A Human Performance approach leans on structured methods that assess a site’s processes where human error presents the most risk, then implementing solutions that stop these errors at the source. The resulting solutions may be cultural, procedural, or technical in nature, and could fall within any department or workstream of the business where humans are involved. Eliminating deviations, particularly recurring ones, will allow your site to move product to market more quickly and efficiently.

This blog explores the factors within an organization’s control that impact ongoing human performance.