Batch record template: fields for a small maker's sheet

Batch record template: the fields 21 CFR 111.260 lists

This batch production record template follows 21 CFR 111.260, which lists what the batch production record of a dietary supplement must include. The table doubles as a batch production record example: copy its rows into a sheet.

The rule lists more lines: the unique identifier of each component (d), the date and time equipment was maintained, cleaned and sanitized (c), the actual results of any monitoring operation (g), documentation that the finished supplement meets specifications (i), and packaging and labeling operations documented at the time of performance (k).

Lay the sheet out with one line for every step of the master manufacturing record, because the batch production record must follow it (21 CFR 111.255(c)). For manual operations, 21 CFR 111.210(h)(3)(ii) asks for one person weighing or measuring a component and another verifying it, and 21 CFR 111.260(j)(2) asks for the initials of both, so keep two initials columns.

21 CFR 211, the rule for drugs, uses other names and is not covered here. See the master manufacturing record template for the record this one follows. To see where BatchBuddy puts electronic batch records on its plan cards, use the Try BatchBuddy button.

Cosmetic batch record template and food manufacturing batch record template

Part 111 covers dietary supplements. For cosmetics, FDA's MoCRA page lists a draft guidance on good manufacturing practices and no final rule, so the fields above are a sensible start for a cosmetic batch record template, not rule text.

For food, part 117 is FDA's food CGMP rule, and 21 CFR 11.1 says part 11 does not apply to records required by part 117. The same fields are a start for a food manufacturing batch record template, not part 117 text.

Batch record template Excel: what part 11 asks

A spreadsheet is an electronic record under 21 CFR 11.3. For a dietary supplement, 21 CFR 111.605(c) says all electronic records must comply with part 11, so the Excel file has to meet that test.

21 CFR 11.10 lists what part 11 asks of the system: validation, limited access to authorized individuals, secure time-stamped audit trails, and record changes that do not obscure earlier entries. A paper original is allowed too: 21 CFR 111.605(b) lets records be kept as originals, true copies or electronic records.

When a template stops being enough

BatchBuddy's plan cards put electronic batch records on Manufacturer, up to 15 members at $749 a month, billed monthly, as read on November 1, 2026, and its FAQ says existing formulas upload as CSV files with each import logged to the audit trail. Supplement batch record software compares it with its rivals.

BatchBuddy says its form stops an operator from skipping a step, and that batches cannot be released to shipping without a QA e-signature. Other vendor pages differ on the plan. Ask whether old batch records can be loaded, because the CSV import is described for formulas and ingredient lists. BatchBuddy's 14-day free trial starts with no credit card.

A maker whose paper record carries every field above can keep it, as can one whose Excel record also meets part 11: BatchBuddy's own guide says Part 111 requires no particular record format. The batch record review checklist covers the sign-off before release.