21 CFR 111.15 governs the physical plant and grounds — pest control, drainage, lighting, ventilation, water supply, plumbing, sewage, washing facilities, refuse, sanitary operations and the written sanitation procedures and master sanitation schedule. The MSS lists every cleanable surface, the frequency, the responsible role and the verification method — and is one of the documents an FDA investigator asks for in the first 30 minutes.

Regulatory anchors

21 CFR 111.15

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.

Related terms

Personnel hygiene (21 CFR 111.10)

Sanitation (21 CFR 111.15)

Next step

Sanitation (21 CFR 111.15)

Next step