Inside cGMP: What the Standard Actually Requires

What the letters mean

Current Good Manufacturing Practice is a body of regulation describing how a product must be made, tested, documented and controlled so that it consistently meets its specifications. The emphasis is on consistency and traceability rather than on any single test result.

In the United States, dietary supplements fall under 21 CFR Part 111. Drugs fall under 21 CFR Parts 210 and 211. These are genuinely different standards with different requirements, and a product made under one should not be described as if it met the other.

What it requires in practice

Written specifications for every incoming material and every finished product. Identity testing on incoming components rather than trusting the supplier certificate. Validated and calibrated equipment. Trained personnel with documented training. Controlled, documented processes with batch records created as work happens.

Also: designated quality personnel with authority to reject material, full traceability from raw material lot to finished lot, stability programmes supporting expiry dates, investigation of deviations and out-of-specification results, reserve samples retained, and a complaint and recall procedure that has been tested.

The phrase to be careful with

"Manufactured in a cGMP-certified facility" does a lot of quiet work. A facility can hold third-party certification while a specific product made in it was not manufactured under full compliance. Facility-level and product-level claims are not the same.

There is also no FDA cGMP certificate to hold. FDA inspects and issues observations; it does not award certification. Third-party auditors such as NSF or UL do certify, and that is a real but different thing.

Why documentation is the substance

The saying in quality circles is that if it is not written down, it did not happen. cGMP is substantially a documentation discipline: batch records, deviation reports, change control, training files, calibration logs.

That is what makes a recall possible. Without lot-level traceability, a contamination problem cannot be bounded — you cannot tell which units are affected, so you cannot tell customers anything useful.

What to ask

Which regulation — supplement cGMP or drug cGMP? Is the claim about the facility or about this product? Who audits, and when were they last there? Is there lot traceability from raw material to finished unit? Is there a written recall procedure?

These are ordinary questions any compliant manufacturer can answer without hesitation.