How-to guides

How to build master and batch records for a dietary supplement

Step-by-step help for building a master manufacturing record template from 21 CFR 111, linking it to the batch record and testing it before first use.

Build a master record template that covers the rule text and know when software would help.

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Master manufacturing record template: what to include, step by step

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A master manufacturing record template for dietary supplements built from 21 CFR 111.205 and 111.210: required fields, the batch record link and checks.

Bottom line: A master manufacturing record is a written recipe and control plan that 21 CFR 111.205 requires for each unique supplement formulation and each batch size. Section 111.210 lists what it must include, from components and weights to theoretical yield, written steps and corrective action plans. The batch production record then follows it step by step.

Buying guide

Supplement batch record software: do you need it, and which option fits a small maker?

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Does a small supplement maker need batch record software yet? What 21 CFR 111 asks of the records and how six software routes compare, read November 1, 2026.

Bottom line: Not necessarily yet. The dietary supplement rule requires a batch production record for every batch but lets records be kept as originals, true copies or electronic records, and it names no software. Software earns a look when record volume, signers or outside requests outgrow paper, and electronic records must meet 21 CFR Part 11.