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The batch record, and the fields that matter

Updated October 2026

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The fields Amounts actually used, not intended Deviations are recorded, not hidden The identity verification belongs here Write it during, not after Keep it well past the shelf life One record per batch, signed References

This is the document cGMP is really asking for, and three entries carry it: what went in, what you did, what came out.

The fields

Batch code and date.
Each ingredient: supplier, their lot, your identity verification and its date.
Amounts actually weighed, not the recipe amounts.
Carrier and its strength.
Process: start, duration, any deviation and who approved it.
Yield, and what was lost to filtering or settling.
Bottles filled, the lot code on them, and where they went.
Reserve sample location.

Amounts actually used, not intended

The recipe says what should happen; the record says what did. A batch record that reproduces the formula is not a record, and the difference matters precisely when somebody is trying to understand a batch that went wrong.

Deviations are recorded, not hidden

Something will run long or come up short. Writing down what happened and who decided what to do about it is what a procedure is for, and an unblemished record across hundreds of batches is less credible than one with deviations handled properly.

The identity verification belongs here

Not in a separate pile. The point of the record is that a bottle can be traced back through the batch to the verified material it was made from, and splitting that chain across two systems breaks it.

Write it during, not after

A record completed at the end of the week records what you remember. It has to be at the bench and quick enough to fill in while the work happens.

Keep it well past the shelf life

Questions about a supplement arrive late, and the retention expectations in this category are longer than the product lasts. Treat the records as the thing you keep rather than the product.

One record per batch, signed

A shared notebook with entries in several hands and no attribution is not a controlled record. Naming who did each step is part of what makes it evidence rather than notes, and it matters most on the days when somebody other than you made the product.

Store them somewhere a fire or a lost laptop cannot take them, because they are the only evidence that the product was made the way you say.

References

21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. law.cornell.edu

Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.