Last Updated on October 24, 2025 by Hafsa J.

Why the ISO 22716 Master-Batch Record Template Matters

If you’ve ever sat in front of an auditor explaining how your team tracks every batch, you know how tense that moment can be. In my experience helping cosmetic manufacturers prepare for ISO 22716 audits, most headaches start with one thing—incomplete or inconsistent batch documentation.

That’s where the Master-Batch Record (MBR) comes in. It’s not just a form—it’s your blueprint for manufacturing consistency, traceability, and product safety.
When it’s designed well, it helps you:

• Prove that each batch follows approved instructions
• Reduce production errors and rework
• Build confidence during inspections and customer reviews

This article walks you through what a compliant MBR looks like, how to structure it, and how to train your team to actually use it. I’ll also share a few lessons from real audits that might save you a sleepless night or two.

Understanding the Role of the Master-Batch Record in ISO 22716 Compliance

Before diving into templates, it’s worth understanding why ISO 22716 insists on a Master-Batch Record.
It’s the official, approved recipe for your product—documenting every material, step, and checkpoint before manufacturing even starts.

Here’s what I’ve noticed: companies often confuse the Master-Batch Record (MBR) with the Batch Production Record (BPR).
Think of it like this:

• The MBR is your master plan.
• The BPR is the execution log of that plan for a specific batch.

When auditors review your process, they look for alignment between the two. If they don’t match, that’s a red flag.

Pro tip: Always include a version-control line on your MBR and link it to your document-control system. That way, no operator ever works from an outdated version.
Common mistake: Teams rely on printed instructions from last year—then realize too late that the formulation changed.

Essential Sections of a Master-Batch Record Template

Here’s what every solid MBR should include. Don’t overcomplicate it—focus on clarity and traceability.

1. Product Information

Include product name, internal code, version, and date of approval.
Auditors use this to verify document control.

2. Formula Composition

List all ingredients, their INCI names, and percentage composition.
Pro tip: Always round to consistent decimals (e.g., 0.01%) to prevent confusion during weighing.

3. Raw-Material Batch Numbers

Each material used must trace back to a supplier and lot number.
If there’s ever a recall, this step will save you hours.

4. Equipment & Premises Used

Record equipment ID, cleaning verification, and calibration status.
Example: One client avoided a major non-conformity because their MBR clearly referenced the mixer’s calibration certificate.

5. Manufacturing Instructions

Lay out steps in clear, sequential order—quantities, temperatures, mixing times, and hold points.
Avoid vague phrases like “mix until uniform.” Define measurable parameters.

6. In-Process Controls

Document checkpoints such as pH, viscosity, or temperature readings.
Pro tip: Add a “Record of Deviation” line right under each test. It makes your QA review smoother.

7. Packaging & Labelling Details

Include packaging material codes, label approval references, and sign-offs for inspection.
Pitfall: Forgetting to record label revisions—this has caused countless labeling non-conformities.

8. Final Release & Sign-Offs

Your QA or authorized personnel should sign off on batch approval.
Keep space for dates and comments.

When done right, your MBR doesn’t just meet ISO 22716—it tells the story of how your product was made from start to finish.

Formatting & Control: Versioning, Authorization, and Review

This is where many small manufacturers stumble. A good MBR isn’t static—it evolves with your processes.

Here’s how to stay in control:

• Assign each MBR a document number and version.
• Record who prepared, reviewed, and approved it.
• Review it at least once a year—or after any formulation, supplier, or equipment change.

Pro tip: Use a digital document-management system if possible. It automatically locks old versions and tracks user changes.
Common mistake: Keeping multiple paper copies across departments. That’s how outdated instructions slip into production.

One cosmetic lab I worked with had three slightly different versions of their lotion MBR floating around. Once they switched to centralized digital templates, audit findings dropped to zero.

Linking the MBR to Supporting GMP Records

ISO 22716 doesn’t work in isolation—everything connects.
Your MBR should reference these supporting records:

• Raw-material specifications
• Equipment cleaning logs
• Calibration certificates
• Change-control records
• Product release forms

Here’s an example: during an audit, a manufacturer was questioned because their MBR referenced a cleaning SOP that had been updated—but the template still cited the old version. That’s how traceability breaks down. Cross-linking your documents avoids this.

Training Operators and QA Staff on Using the MBR Template

Even the best template fails if your team doesn’t understand it.
Training isn’t just a one-time event—it’s part of your quality culture.

Start by walking operators through a mock batch using the actual form. Show them how to record data clearly, avoid overwriting entries, and document deviations properly.

Pro tip: Use real-world examples during training. Show what a “good” and “bad” record looks like.
Mistake to avoid: Assuming operators will understand phrases like “record as per SOP.” Spell out what “as per SOP” means in practice.

When QA reviews become part of daily habits instead of last-minute panic, compliance gets much easier.

Digital vs Paper MBRs – Which Format Fits Your Operation

There’s no one right format—it depends on your setup.

Digital templates:

• Easier to search, update, and control
• Built-in audit trails
• Ideal for growing companies

Paper templates:

• Simple for smaller facilities
• Low-tech, but prone to loss or manual errors

One of my clients, a small skincare startup, began with paper forms but transitioned to a digital system after struggling to track revisions. Within months, they cut record-review time in half and impressed auditors with their new setup.

Pro tip: Start with a standardized paper template first. Once your team’s comfortable, migrate it to digital.

FAQs: Master-Batch Record Use and Compliance

Q1. Is a Master-Batch Record mandatory under ISO 22716?
Yes. It’s required for demonstrating that every batch follows approved, controlled procedures.

Q2. How often should we review or update the MBR?
At least annually—or whenever there’s a change in formulation, process, or supplier.

Q3. Can we use Excel or Word for our template?
Absolutely. Just make sure it’s version-controlled and approved within your document-control system.

Build Compliance Confidence with the Right Template

If there’s one thing I’ve learned from helping cosmetic manufacturers pass ISO 22716 audits, it’s this—a strong Master-Batch Record is your first line of defense.
It shows consistency, control, and professionalism.

Your MBR doesn’t have to be complex—it just has to be clear, compliant, and consistently used.
If you’re starting from scratch, use a standard template, refine it through a few production runs, and let your team’s feedback shape the final version.

Ready to simplify your GMP documentation?
Download our ISO 22716 Master-Batch Record Template and customize it for your own facility.