Sig Verification in Pharmaceutical Manufacturing: What It Means and Why It Matters

When you take a generic pill, you trust it works just like the brand-name version. That trust comes from sig verification, the process of confirming that every step in drug production is accurately recorded, signed off, and legally traceable. Also known as signature verification, it’s not just paperwork — it’s the backbone of drug safety.

Without proper sig verification, a single error in a batch record could mean a contaminated medicine reaches shelves. The CGMP guidelines, the FDA’s rules for how drugs must be made, tested, and documented, demand that every action — from mixing ingredients to sealing bottles — has a digital or handwritten signature tied to a real person, date, and time. This isn’t about bureaucracy. It’s about catching falsified data before it turns into a deadly mistake. The FDA’s 2025 crackdown on data integrity failures, including backdated logs and deleted records shows how serious this is. Companies that skip or fake sig verification don’t just risk fines — they risk lives.

Sig verification connects directly to how generics are approved. The 80-125% rule for bioequivalence only matters if the lab data behind it is real. If someone tampers with the test results, a generic drug might look safe on paper but fail in your body. That’s why FDA inspectors spend hours reviewing electronic signatures during FDA inspections, the unannounced audits of manufacturing sites. They check if the person who signed off on a batch was even working that day. They look for patterns — like 50 signatures from the same person at 3 a.m. every night. These aren’t red flags. They’re warning signs.

It’s not just about big manufacturers. Even small compounding pharmacies need sig verification when they make custom doses. If a pharmacist signs off on a steroid blend without verifying the raw materials, someone with diabetes could get a dangerous dose. That’s why the FDA now requires electronic signatures for all critical steps — paper logs are too easy to alter. And it’s not just the U.S. The EU, Canada, and Australia all use similar systems. This isn’t a local rule. It’s a global standard.

What you’ll find in these articles isn’t theory. It’s real cases: a plant banned for falsifying batch records, a pharmacist caught backdating logs, a generic drug recalled because no one verified the active ingredient. These aren’t outliers. They’re symptoms of a system under pressure. And understanding sig verification helps you see why some drugs are safer than others — even if they cost the same.