How Small Pharma Companies Can Simplify Quality Compliance

In part 3 of a 3-part interview, Susan Schniepp, Regulatory Compliance Associates Inc., makes a candid argument maintaining a robust pharmaceutical quality system doesn't have to be as complicated as the industry often makes it out to be.

During PDA Week 2026, Schniepp breaks down the fundamentals of a sound quality system, document control, validated methods, validated manufacturing processes, thorough technology transfer, and strong investigation procedures, and insists that the framework itself is straightforward. The real challenge isn't the system; it's having the right people to run it. As she put it, "What's hard to maintain is the proper ratio of people to run the systems and people to interpret the data, because sometimes you get an interesting investigation, one that requires a lot of manpower."

She also pushes back against the tendency of smaller and virtual companies to overengineer their quality documentation by copying requirements from larger organizations or regulatory listings without considering whether those procedures apply to their operations. Her advice is if an organization doesn’t perform a function, don't write a lengthy SOP for it. A simple contracted service agreement will suffice.

This pragmatic philosophy extends to her views on the FDA's regulatory framework, which she stated, "It's a beautiful system the FDA has — they don't tell you what you have to do, they tell you what you have to meet." She argues this outcome-based approach gives companies of all sizes the freedom to design quality systems that fit their specific operations.

Schniepp closes with a pointed reminder about CMO and CDMO relationships, that transparency and well-crafted quality agreements are essential. When clients impose duplicative or conflicting standards on contract manufacturers, costs rise and complexity compounds, an outcome that benefits no one.