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

Master manufacturing record template: what the rule requires

Section 111.205 of the dietary supplement rule says you must prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch. The record must identify specifications for the points, steps or stages where control is necessary, and set controls and procedures so each batch meets them.

This template follows that rule, which covers dietary supplements. Food makers should read FDA's part 117 pages and cosmetics makers FDA's MoCRA page instead. The rule text was read from the eCFR on November 1, 2026, and this guide is general information, not legal advice.

Before you start: one record per formulation and batch size

Decide the scope first. A formulation that you make at two batch sizes needs two master records. Give each record a number, a version and an approval line so a changed formula is never confused with the old one.

Gather the formula, the component specifications, the label, the packaging description and the written procedures you already follow. If a contractor makes any part of the batch, agree in writing who holds which record.

Template fields, step by step

• Header: the product name, and the strength, concentration, weight or measure of each dietary ingredient for each batch size.
• Components: a complete list of components and an accurate statement of the weight or measure of each.
• Label link: the identity and weight or measure of each dietary ingredient declared on the Supplement Facts label, and each ingredient on the ingredients list.
• Overage: a statement of any intentional overage of a dietary ingredient.
• Yield: theoretical yield at each control point and at the end, with the maximum and minimum percentages beyond which a deviation investigation and material review are needed.
• Packaging: a description of the packaging and a representative label, or a cross-reference to where the label is kept.
• Written instructions: specifications for each control point, sampling procedures with a cross-reference to the tests, and the specific actions to perform and verify each step.
• Second-person checks: for manual operations, one person weighs or measures a component and another verifies, and one person adds it and another verifies the addition.
• Notes and corrective action: special notations and precautions, and corrective action plans for when a specification is not met.

How the batch production record follows the master

Section 111.255 requires a batch production record every time a batch is made, with complete information on its production and control. It must accurately follow the master record, and each step must be performed. Section 111.260 lists what the batch record carries: the batch or lot number, the equipment and processing lines used, the unique identifier of each component, the weight or measure of each component used, actual yield and percentage of theoretical yield, test results, and the date and initials of the people who did each step, including weighing, verifying and adding. Quality control personnel must document their review and their approval or rejection of the batch for release.

Design the batch sheet so it has a line for every master step, with space for the date, initials and the second-person check.

Test the template and verify the records before first use

• Dry run: fill the template for a past batch and mark every field you could not complete from existing records.
• Cross-check: confirm each master field in 111.210 appears, and each batch field in 111.260 has a place on the batch sheet.
• Second-person test: confirm the verifier is a different person from the one who weighed or added.
• Deviation test: set a yield outside the stated limits and confirm the sheet leads to an investigation and a disposition record.
• Review: ask a qualified regulatory consultant or counsel to review the template before first use.

Keeping the record: retention and electronic copies

Section 111.605 says to keep written records for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch associated with the records. Records may be kept as original records, true copies or electronic records, and all electronic records must comply with part 11. Section 11.10 lists controls for such systems, including limited system access and secure, time-stamped audit trails that do not obscure earlier entries.

Some batch record software builds this structure for you. BatchBuddy's FAQ, for example, describes a locked master manufacturing record with versioned change orders approved by a different user. The software guide shows how to compare such tools, and the BatchBuddy review reads its terms.