Purified Water (PW) for dietary supplement use is qualified against USP monograph limits of Total Organic Carbon ≤500 ppb (USP <643>) and conductivity ≤1.3 µS/cm at 25°C (USP <645>, three-stage test), plus microbial limits (typically ≤100 CFU/mL action level). The PW loop must be sanitisable, dead-leg <6×D, and continuously recirculated; an unmonitored softener+RO+UV is not USP PW unless the spec is qualified.

Regulatory anchors

USP <643>
USP <645>
USP <1231>

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.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Purified water (USP <643>/<645>)

Next step

Purified water (USP <643>/<645>)

Next step