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MMR elements per 21 CFR 111.205

TL;DR

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 e...

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 engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
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/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Related terms
BPR elements per 21 CFR 111.255MMR 111 210
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