The Master Manufacturing Record (MMR) under 21 CFR 111.205 must be prepared for each unique formulation and each batch size of a dietary supplement, and must contain: name & strength; complete list of components by established name; accurate statement of weight or measure of each; identification of each point/step requiring quality control verification; written instructions including specifications for each step; sampling and test instructions; corrective-action plan when a spec is not met. Missing any one is the recurring 483 in supplement inspections.

Regulatory anchors

21 CFR 111.205
21 CFR 111.210

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.

MMR elements per 21 CFR 111.205

Next step

MMR elements per 21 CFR 111.205

Next step