Master Manufacturing Record (MMR) – GMP Compliance from Batch Planning to Release
A Master Manufacturing Record (MMR) defines the approved recipe, method, and controls for producing a product batch. Required by 21 CFR Part 111 and 21 CFR Part 11, the MMR ensures that every production run follows a validated and repeatable process. Without an accurate MMR, every batch is a risk—of non-compliance, inconsistency, and product rejection.
V5 from SG Systems Global enforces Master Manufacturing Records digitally, linking every step—ingredients, equipment, operator actions, and quality controls—to the MMR in real time. It transforms paper-based protocols into paperless execution and electronic traceability, ensuring that what’s planned is exactly what gets made.
“With V5 enforcing our MMRs, we’ve eliminated skipped steps, undocumented changes, and manual errors. It’s compliance we can trust.”
— QA Manager, Supplement Manufacturer
What Is a Master Manufacturing Record?
The MMR is the blueprint for manufacturing a regulated product. It defines the process that must be followed to ensure product quality, safety, and consistency. Each Batch Manufacturing Record (BMR) is derived from the MMR and documents how the specific batch followed the master instructions.
According to 21 CFR Part 111 and GMP principles, an MMR must include:
- Product name and strength
- Ingredient list with quantities and specifications
- Manufacturing steps in correct sequence
- Equipment and environmental parameters
- In-process testing and acceptance criteria
- Packaging, labeling, and batch coding instructions
- Sign-off requirements and responsible personnel
The MMR is often confused with the Batch Manufacturing Record (BMR), which records the actual execution. The MMR is the standard; the BMR is the evidence.
Why MMR Compliance Matters
Regulators expect every batch to be manufactured precisely as specified in the Master Manufacturing Record. Failure to follow the MMR—even minor deviations—can lead to:
- Product recalls or quarantine
- FDA 483 observations and warning letters
- Invalidated batches and rejected product
- Risk to consumer safety and brand reputation
Without enforced adherence to the MMR, compliance is theoretical at best. That’s where systems like V5 enforce real-world control, every shift, every batch.
Digital MMR Enforcement with V5
With V5, the MMR becomes an enforceable digital standard across your operation. V5 ensures every material, instruction, person, and result aligns to the master record—capturing each step electronically and enforcing validation before moving forward.
Capabilities include:
- Live production control tied to MMR instructions
- Digital sign-offs with enforced sequence logic
- Checklists, validations, and 4-eyes sign-off enforcement
- Real-time alerts for skipped or out-of-spec steps
- Deviation escalation to CAPA workflows
- Audit-ready documentation across batches
Everything that happens during production is tracked against the MMR—with full traceability and compliance with 21 CFR Part 11.
How MMRs Relate to BMRs and eBRs
Each Batch Manufacturing Record (BMR) is based on the MMR—it captures how that specific batch was executed. When digitized, the BMR becomes an Electronic Batch Record (eBR), combining real-time data capture with procedural enforcement.
In this hierarchy:
- MMR = The approved manufacturing standard
- BMR = The execution record for one batch
- eBR = The digital version of the BMR, with automation, compliance logic, and live traceability
All three must align. V5 ensures they do—by controlling execution, capturing every action, and making batch release fast and audit-ready.
Regulations That Mandate MMRs
MMRs are a regulatory requirement under:
- 21 CFR Part 111 – Dietary Supplements
- 21 CFR Part 211 – Pharmaceuticals
- 21 CFR Part 820 – Medical Devices
- ISO 13485 – Quality management for medical device manufacturers
- EU GMP Annex 11 – Computerized system compliance in the EU
With the right digital infrastructure, compliance with these regulations becomes routine—not reactive.
Standardize, Automate, and Control with V5
Master Manufacturing Records are only as effective as your ability to enforce them. V5 ensures that the process defined in the MMR becomes the reality on your production floor—with digital visibility, enforced logic, and full traceability built in.
Whether you’re manufacturing capsules, powders, liquids, or devices, V5 enforces what matters—consistency, quality, and compliance at scale.
Contact us to schedule a demo or request a sample MMR+BMR+eBR workflow showing how V5 unifies compliance from master to batch to release.
