What you have to write down

Two very different answers, and which one applies to you was settled by the cosmetic-or-drug determination.

Cosmetic, and what safety substantiation needs

There is no prescribed cosmetic batch record format, which people read as no obligation. The obligation is adequate substantiation of safety, and it has no small-business exemption.

Substantiation is evidence about your finished product: what is in it, at what level, with supplier documentation for each material, and a reasoned basis for believing it is safe for its intended use.

That evidence is assembled from records. A maker with no batch records cannot substantiate anything about a product they made last year.

The batch record

Batch code and date. Formula with the actual weights. Lot number of every material. Melt temperature, pour temperature, cooling method. Units filled, units rejected. Where they went.

Plus the reference tubes, which are a record in physical form and the only one that answers "was it like this when it left?"

The batch code has to be on the tube or on the carton, or the record cannot be connected to a product in somebody's hand.

Drug-side records are a different thing

Under cGMP, records are prescribed rather than sensible: master production records, batch production records, component testing and release, deviation handling, and specified retention.

That is a documentation system rather than a notebook, and it is the part of the drug route that most underestimates a small operation.

The retrieval test

Hand yourself a tube with a code on it. How long to produce the formula, the lot numbers of every material in it, the process figures, and the list of who received that batch?

Under an hour is a working system. A day means you have notes rather than records. Run it on a quiet afternoon rather than on the day it matters.

References