ABSTRACT
It is required by §111.205 to establish written master manufacturing records (MMRs), a vital part of the production and process control system. These are documents that spell out in detail how each unique formula and each batch size of each dietary supplement must be made, that is, step-by-step instructions for the entire production process. MMRs can be considered as the equivalent of recipes, which spell out the ingredients, quantities of each needed, and then detailed ways of putting them together to make the finished product. A point where the analogy between an MMR and a recipe is not necessarily fully accurate in that, generally, in making a food product according to a recipe it does not matter whether the ingredients and procedure are followed with great precision, as some leeway is usually tolerable, but in the case of dietary supplement manufacturing, even minor variations are unacceptable.
