Example MMR (Solid Unit Doses) and Master Formula Form

Manufacturing – MMR and BPR (Parts H & I)

Example MMR (Solid Unit Doses) and Master Formula Form

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Published: Thursday, April 1, 2010

This is an example of an MMR for a solid-unit-dose operation such as encapsulation or tableting. The first page is a cover page used to summarize production planning information and the progress of the production order. Companies may modify the cover page as appropriate for their operations, or may omit it entirely.

21 CFR part 111 requires master manufacturing records (MMRs) to include the following ingredient information for each batch size: the identity of all ingredients and other components; the potency, strength, or concentration of each; the quantity of each ingredient and component to be used in the batch; the quantity of each dietary ingredient that will be stated in the product’s Supplement Facts box; and the amount of any intentional overage used above and beyond the quantity required to meet the Supplement Facts claim. Much of this information may be conveniently summarized in a “Master Formula” document such as this. In this example, the Master Formula is designed primarily to summarize the information required for labeling purposes; as such it does not include, for example, water which might be used with the starch to form a granulate or solvents included in the tablet coating solution. In this case, the identity and quantity of such inputs as granulation solutions or coating solutions would have to be specified elsewhere in the MMR, e.g. on the Dispensing page of the MMR. Other companies prefer to combine the Master Formula and the Dispensing onto one page of the MMR.

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