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What you have to write down

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In most categories records prove you did the right thing. Under 21 CFR 111 the records are a substantial part of what the right thing is.

Records are the rule, not evidence of it

The rule requires written specifications, documented identity verification, batch production records, a quality unit review, and reserve samples. A manufacturer who blends carefully and writes nothing is non-compliant regardless of product quality.

That framing is worth internalizing early, because it is the opposite of how most small makers think about paperwork.

Five records that join up

The specifications: components, packaging, labels, finished product.

The supplier and material record: qualification, certificates, identity results, lot numbers.

The master formula and process, versioned.

The batch production record, one per batch, linking everything above to the units produced.

The test results: uniformity, potency, and anything else you ran.

Separately they are paper. Joined, they answer the only question that matters: what is in this tub and how do you know.

Reserve samples

The rule expects reserve samples of finished batches held for a defined period, stored under conditions that protect them.

They are what lets a later question be settled by testing rather than by argument, and they are the only way to examine what you actually shipped rather than what you recorded.

Label with the batch code, seal properly, store as the product should be stored.

How long, and where

Records and reserve samples for the periods the rule specifies, which extend beyond the product's shelf life. Adverse events and questions arrive late.

Keep it somewhere that is not only your laptop. And write it so a competent stranger could follow it, because an inspection, a buyer's audit and a problem investigation are all exactly that situation.

References

21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. In force for all manufacturers regardless of size since June 2010. ecfr.gov
Written from published regulation and peer-reviewed work, not from a laboratory of our own. Your own certificates of analysis, your blend uniformity results and your own written specifications override anything general said here. Nothing on this site is a substitute for the records 21 CFR 111 requires you to keep.