The equipment a supplement is made on

Three written procedures, named individually

Most subparts of the supplement manufacturing rules open with a general instruction to write procedures. This one names three.

Procedures for calibrating instruments and controls used in manufacturing or testing a component or supplement.

Procedures for calibrating, inspecting and checking automated, mechanical and electronic equipment.

And procedures for maintaining, cleaning and sanitizing, as necessary, all equipment, utensils and any other contact surfaces used to manufacture, package, label or hold components or supplements.

Naming them individually means each is separately checkable. A firm cannot satisfy this section with one general document if the three subjects are not covered.

What counts as equipment

The section defines its own scope with a list rather than a definition, which makes it broader than the word usually suggests.

Equipment used to hold or convey. Equipment used to measure. Equipment using compressed air or gas. Equipment used to carry out processes in closed pipes and vessels. And equipment used in automated, mechanical or electronic systems.

The design standard is that equipment and utensils be of appropriate design, construction and workmanship to be suitable for their intended use and to be adequately cleaned and properly maintained.

Then a list of what design and construction must prevent getting into the product: lubricants, fuel, coolants, metal or glass fragments, filth or any other extraneous material, contaminated water, or any other contaminants.

Materials, seams and the physical detail

Five material requirements apply to all equipment and utensils in use.

Installed and maintained to facilitate cleaning the equipment, the utensils and all adjacent spaces. Corrosion-resistant if they contact components or supplements. Made of nontoxic materials.

Designed and constructed to withstand the environment they are used in, the action of the components or supplements, and where applicable the cleaning compounds and sanitizing agents. And maintained to protect components and supplements from being contaminated by any source.

Seams get their own paragraph. They must be smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles or any other extraneous materials or contaminants.

Compressed air or other gases introduced mechanically into or onto a component, supplement or contact surface, or used to clean one, must be treated so nothing is contaminated.

Cold storage, and the two devices it needs

One paragraph is directly relevant to anything stored cold, and it requires two separate things.

Each freezer, refrigerator and other cold storage compartment used to hold components or supplements must be fitted with a temperature device. The regulation names three kinds: an indicating thermometer, a temperature-measuring device, or a temperature-recording device. It must indicate and record the temperature accurately within the compartment, or allow for recording by hand.

And it must have an automated device for regulating temperature, or an automated alarm system to indicate a significant temperature change in a manual operation.

That is measurement plus a response mechanism. A cold room with a thermometer and nothing else does not meet the second half.

Instruments, and the three qualities they need

Instruments and controls used in manufacturing, packaging, labeling or holding, and those used to measure, regulate or record temperature, pH, water activity or other conditions controlling microbial growth or contamination, have three requirements.

They must be accurate and precise. Adequately maintained. And adequate in number for their designated uses.

That third one is easy to skim past. Having the right instrument is not enough if there are not enough of them for the work being done.

Calibration has a schedule with three triggers

Calibration is required for instruments and controls used in manufacturing or testing a component or supplement, and the section states when.

Before first use. At the frequency specified in writing by the manufacturer of the instrument and control. Or at routine intervals, or as otherwise necessary to ensure accuracy and precision.

Before first use is the unambiguous one. A new instrument is calibrated before it does any work, not after a period of service.

And there is an end state for an instrument that fails: "You must repair or replace instruments or controls that cannot be adjusted to agree with the reference standard."

Cleaning between batches, and when it is required

Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning and sanitizing.

Contact surfaces used for low-moisture components or supplements must be in a dry and sanitary condition when in use. Where they are wet-cleaned they must be sanitized when necessary and thoroughly dried before subsequent use.

Wet processing triggers a stricter rule. Contact surfaces must be cleaned and sanitized as necessary to protect against the introduction of microorganisms. Where that is necessary, it must happen before use and after any interruption during which a surface may have become contaminated.

For continuous production, or consecutive operations involving different batches of the same supplement, contact surfaces must be adequately cleaned and sanitized as necessary.

Surfaces that do not directly contact product still get cleaned, as frequently as necessary to protect against contaminating what does.

Automated equipment answers to quality control

Automated, mechanical or electronic equipment used to manufacture, package, label or hold a supplement carries five requirements, and two of them route through quality control personnel.

The equipment is designed or selected to ensure specifications are consistently met, and its suitability is determined by ensuring it can operate satisfactorily within the operating limits the process requires.

It is routinely calibrated, inspected or checked to ensure proper performance — and quality control personnel must periodically review those calibrations, inspections or checks.

Controls must ensure that any changes to manufacturing, packaging, labeling, holding or other operations are approved by quality control personnel and instituted only by authorized personnel. The regulation states that this covers software for a computer controlled process.

And controls ensuring the equipment functions in accordance with its intended use must themselves be approved by quality control personnel.

The calibration record has seven fields

This subpart's records section is unusually specific, and the calibration record is the most detailed item in it.

Documentation of any calibration, each time one is performed, must identify the instrument or control calibrated and provide the date.

It must identify the reference standard used, including the certification of accuracy of that known reference standard and a history of recertification of accuracy.

It must identify the calibration method used, including appropriate limits for accuracy and precision. It must give the calibration reading or readings found.

Where accuracy or precision limits were not met, it must identify the recalibration method used and the readings found. And it must include the initials of the person who performed the calibration and any recalibration.

Equipment logs, and a backup rule

Two more record categories are worth naming.

Documentation in individual equipment logs of the date of use, maintenance, cleaning and sanitizing of equipment, unless that documentation is kept with the batch record.

And backup files of current software programs, of outdated software needed to retrieve required records where current software cannot, and of data entered into computer systems used to manufacture, package, label or hold supplements.

The backup has a quality standard. The regulation requires that a backup file "must be an exact and complete record of the data you entered." Backup software and data must be kept secure from alterations, inadvertent erasures, or loss.

What this is worth to a reader

This subpart is where the supplement rulebook gets concrete enough to ask about. Calibration before first use, a documented reference standard with a recertification history, initials on each calibration, and a repair-or-replace rule for instruments that will not agree.

For anything stored cold, the two-device requirement is a usable idea: a way to know the temperature, plus an automated way to regulate it or raise an alarm.

These obligations bind whoever manufactures, packages, labels or holds the product. A brand that outsources all of that is not the party the section governs.

And none of these records are published. They exist for an inspection. Nothing here describes any specific facility or seller.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. 21 CFR 111.25, What are the requirements under this subpart D for written procedures? — Electronic Code of Federal Regulations, title 21, August 2026
2. 21 CFR 111.27, What requirements apply to the equipment and utensils that you use? — Electronic Code of Federal Regulations, title 21, March 2008
3. 21 CFR 111.30, What requirements apply to automated, mechanical, or electronic equipment? — Electronic Code of Federal Regulations, title 21, August 2026
4. 21 CFR 111.35, Under this subpart D, what records must you make and keep? — Electronic Code of Federal Regulations, title 21, August 2026