Total Organic Carbon (TOC) is the workhorse cleaning verification analyte for shared-line supplement plants because it captures any carbon-bearing residue (active, excipient, cleaner). Swab samples a defined surface area (typically 25–100 cm²) to detect localised residue; rinse samples a full equipment volume to detect uniform residue. A defensible cleaning programme runs both, ties each to a MACO limit, and only allows visual-only release once the cleaning is validated.

Regulatory anchors

FDA Cleaning Validation Guide
21 CFR 111.27

How V5 handles it

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

TOC swab vs rinse (cleaning verification)

Next step

TOC swab vs rinse (cleaning verification)

Next step