Master Manufacturing Record (MMR)
RegulatoryAlso known as: MMR, Master Batch Record, Master Production Record
Written specification for how every batch of a finished supplement is to be made, required by 21 CFR §111.205.
What It Means
An MMR is a product-specific manufacturing specification under 21 CFR Part 111 Subpart E. It captures the formula (each component identity and quantity), the production and process controls, the in-process and finished-product specifications, packaging and labeling specifications, and any deviations procedure. Each batch produced gets its own Batch Production Record (BPR) documenting what actually happened against the MMR. FDA inspectors review both. A contract manufacturer that cannot produce an MMR for a SKU on demand is signaling a §111.205 finding.
What It Is Not
An MMR is not a recipe, an SOP, or a quality manual. SOPs describe how to perform individual tasks (e.g., calibrate a balance); the MMR is the per-product manufacturing spec. A 'quality manual' is a top-level QMS document; the MMR is product-specific.
Evidence and References
Related Categories
Need Help Understanding Compliance?
Our directory connects you with manufacturers and labs that meet these standards.