Why Robust Quality Systems Save Pharma Companies Millions

In part 1 of a 3-part interview, Susan Schniepp, Regulatory Compliance Associates Inc., sat down with PharmTech, during PDA Week 2026, to discuss the critical importance of quality systems in pharmaceutical manufacturing. Drawing on her experience participating in PDA planning committees and her work interfacing with the FDA on 503B compounding, Schniepp makes a compelling financial case for investing in quality at every stage of production.

At the heart of her argument is a straightforward cost escalation model tied to where in the manufacturing process a defective material is caught. Catching a problem at incoming inspection costs virtually nothing, the material is simply returned. But the price of missing that defect climbs steeply from there. As Schniepp explained, "It costs you $10,000 if it makes it on your shelf. It costs you $20,000 if it makes it to your floor." The numbers continue to rise to $50,000 if the defect enters the batch, $100,000 if it reaches final product, and a staggering $1,000,000 if a full field recall becomes necessary.

Beyond the financial toll, Schniepp emphasizes that recalls carry serious reputational consequences regardless of their severity. "It's the reputation of the company that's at stake whenever there's any kind of recall," she notes, pointing out that even a cosmetic issue like a smeared label can damage how customers perceive a brand.

Ultimately, Schniepp's message is clear: a robust quality system is not merely a regulatory obligation, it is a sound business investment. By catching problems early and consistently, companies can avoid the exponentially higher costs that come with letting defects slip through the cracks.