Quick answer
A compliant supplement Master Manufacturing Record (MMR) defines formula, process, controls, and documentation requirements before production starts.
MMR core sections
- Product identity and batch size targets.
- Component list with specifications and tolerances.
- Manufacturing instructions and in-process controls.
- Packaging and labeling instructions with reconciliation rules.
Review controls
Require QA approval for every revision and maintain versioned records linked to executed batch records.
Common MMR defects
Missing tolerances, unclear process steps, and disconnected label instructions are common audit findings.
Related links
supplement cGMP guide, supplement operations playbook, supplement blog hub.
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