21 CFR 111 Subpart C: Facility Requirements Guide

What does 21 CFR 111 Subpart C actually cover?

Subpart C of 21 CFR Part 111 is titled "Physical Plant and Grounds." It is short: 111.15 covers sanitation of the physical plant and grounds, 111.20 covers design and construction of the physical plant, and 111.23 covers the records you must make and keep. Equipment and utensils sit next door in Subpart D, which runs from 111.25 through 111.35. Section 111.25 is the subpart's scope statement, setting out the requirements under Subpart D for equipment and utensils; the substantive requirements follow in 111.27 through 111.35.

I treat the two subparts as one conversation, because that is how FDA investigators walk a building. They do not stop at the wall and start again at the mixer. When a client asks me about "facility and equipment requirements," they usually mean everything from the parking lot to the calibration sticker on the scale, so this guide covers both.

The rule itself is the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, published in the Federal Register on June 25, 2007 (72 FR 34752). The current text is on eCFR. The staggered phase-in periods have long since ended, so every manufacturer, packager, labeler, and holder covered by 21 CFR 111.1 is expected to be fully compliant.

The legal hook matters too. Under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act, a dietary supplement is adulterated if it was prepared, packed, or held under conditions that do not meet the CGMP regulations. A dirty hallway or a drifting balance is therefore not a paperwork problem. It can make the product legally adulterated.

Who has to comply with the facility rules?

21 CFR 111.1 applies to anyone who manufactures, packages, labels, or holds a dietary supplement. That includes contract manufacturers, private label owners who take on any of those operations, and warehouses that hold finished product. It does not include a brand owner that outsources every step and never touches product, though that owner still carries responsibility for what the contractor releases under its name.

This matters for a question I hear often: "Our finished supplements are made at a factory somewhere else. Do we need a compliant facility?" If you hold inventory, relabel, or repackage, yes. If you truly do nothing physical, your obligation is qualifying the contractor and reviewing its work, which is a different exercise, and Subpart C is the standard you hold that factory to.

111.15: Sanitation of the physical plant and grounds

Section 111.15 is a list of sanitation conditions you must maintain. It reads like common sense, but each item turns into an investigator question. Here is how I translate the main requirements into things you can walk and verify.

Grounds

The grounds around the building have to be kept so they do not become a source of contamination. In practice that means no standing water, no uncut weeds against the wall, no stacked pallets or scrap that shelter pests, and drainage that keeps water away from the foundation and dock doors. Walk the perimeter outside before you worry about the inside. Pests get in where the outside is neglected.

Cleaning compounds, sanitizers, and pesticides

You have to use cleaning and sanitizing agents that are safe and adequate for their purpose, and you have to store toxic materials so they cannot contaminate components, in-process material, or finished product. The rule also restricts pesticide use to circumstances where you have taken precautions against contamination. Practically, this means:

A designated, labeled, access-controlled storage area for chemicals, away from component and packaging storage.
Safety data sheets and a current list of approved chemicals.
Evidence that your pest control contractor's products and application methods are controlled, not just that a contractor shows up monthly.

Pest control

Section 111.15 requires that you prevent animals, birds, and insects from entering the plant, and that you not allow pests in areas where components or product are handled. A pest control program that earns its keep includes a site map of devices, a service log, trend reports, and corrective actions when activity shows up. I think the trend report is the most under-used piece. A binder of service tickets proves a vendor visited, while a trend report proves someone read the results.

Water supply, plumbing, and sewage

Your water supply must be adequate for the operations and, where it contacts components, product, or product-contact surfaces, it must be potable and meet the EPA National Primary Drinking Water Regulations in 40 CFR part 141 (or comparable standards). Plumbing has to carry water in sufficient quantity, with no back-siphonage or cross-connection between potable and non-potable lines. Sewage and liquid disposal has to go into an adequate system without creating a contamination risk.

Document your water source. If you are on municipal water, keep the utility's annual consumer confidence report. If you are on a well, you own the testing, and an auditor will ask for it.

Toilet and hand-washing facilities

Toilet facilities must be adequate, accessible, and kept clean. Hand-washing facilities must be adequate, convenient, and furnish running water at a suitable temperature. The failure I see most often is a hand sink that exists but is blocked by a cart, lacks soap or single-use towels, or sits so far from the production floor that no one uses it.

Trash disposal

Rubbish has to be conveyed, stored, and disposed of so it does not become a harborage for pests or a source of contamination. Covered containers, regular removal, and a dumpster that is not parked against the dock door cover most of it.

111.20: Design and construction of the physical plant

If 111.15 is about how you keep the building, 111.20 is about how the building was made. This is the section that decides whether a pre-construction review has anything to catch, because it is much cheaper to fix a floor plan than a finished warehouse.

The core obligation in 111.20 is that your physical plant be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations. From that single sentence come the requirements investigators actually test.

Adequate space and separation

You must have enough room to place equipment and store materials in an orderly way, and to prevent mix-ups and contamination. Operations that can cross-contaminate (for example, handling a potent botanical powder and a plain excipient, or a major allergen and a non-allergen line) must be separated by location or by other effective means. "Other effective means" gives you flexibility, but you must be able to defend it, usually with a documented rationale and cleaning verification.

You also need defined areas for receiving, quarantine, sampling, storage of released components, manufacturing, packaging and labeling, finished product holding, and rejected material. They do not all need separate rooms, but each status has to be unmistakable, whether by physical zones, labeled locations, or a validated electronic inventory system.

Floors, walls, ceilings, fixtures, ducts, and pipes

Surfaces must be constructed so they can be adequately cleaned and kept in good repair. Fixtures, ducts, and pipes must not contaminate components or product by dripping or condensation. When I walk a facility, I look up. Overhead pipes with condensation, flaking paint, and gaps around penetrations are the findings that make an owner say, "I walk under that every day and never saw it."

Lighting

Lighting has to be adequate in hand-washing areas, dressing rooms, toilets, and areas where components and product are examined, manufactured, or held. Light fixtures over exposed product need shatterproof or protective shields, and broken glass is a hazard you plan for rather than react to.

Ventilation and air control

Ventilation must be adequate to control odors, dust, and vapors, and to keep conditions from contaminating product. Where you have dust-generating operations such as blending or capsule filling, local exhaust and filtered air handling are the practical answer. Temperature and humidity matter as well, since many supplement ingredients are hygroscopic and a warehouse that hits summer extremes can quietly degrade stability.

Cross-contamination controls built into the layout

Look at personnel and material flow on a floor plan. Raw materials should not travel back through finished product areas, and employees should not walk from a receiving dock into a clean filling room without gowning and hand-washing steps. If the paths cross, you either redesign them or you control the crossing in a written procedure and prove it works.

111.23: Records under Subpart C

Section 111.23 requires you to make and keep records of your written procedures for cleaning the physical plant and for pest control, and documentation that you carried them out. The rule does not separately require pesticide-use or cleaning-compound logs, but keeping them is good practice because they show your pest control and cleaning procedures were carried out as written. Under 111.605, you keep records for one year past the shelf-life date of the affected product, or two years beyond the date of distribution of the last batch associated with those records when no shelf-life date is assigned.

The cleaning schedule on the wall is not the record. The record is the signed, dated entry showing what was cleaned, when, by whom, with what, and whether anyone verified it.

Subpart D: Equipment and utensils (111.25 to 111.35)

Equipment is the second half of the facility story. The requirements in Subpart D are about whether the things that touch your product are suitable, clean, calibrated, and controlled.

Design and material suitability

Equipment and utensils must be of appropriate design, construction, and workmanship for their intended use, and must be constructed so surfaces that contact components or product are not reactive, additive, or absorptive in a way that changes safety or quality. Stainless steel is the common answer, though gaskets, seals, and scoops are where plain hardware often fails. Wooden paddles and cracked plastic scoops are not suitable product-contact tools.

Equipment also has to be installed so that it can be cleaned, and so that the area around it is accessible for cleaning and maintenance.

Cleaning, maintenance, and sanitizing

You must keep equipment and utensils clean and, as needed, sanitized, and maintain them in good repair. You need written procedures covering maintenance, cleaning, and sanitizing, and the cleaning procedures should specify who, what agents, what steps, and how you verify. Because 111.27 expects you to prevent contamination, I recommend a visual inspection step before use plus a defined status label such as "Clean, ready for use."

Calibration

Under 111.27(d), instruments and controls used in manufacturing or testing a component or dietary supplement must be calibrated, and the calibration must be suitable for the intended use. That means scales, balances, thermometers, pH meters, metal detectors, and similar devices. A good program has:

An inventory of every critical instrument with a unique ID.
A calibration frequency based on use, risk, and manufacturer recommendation.
Calibration against a known reference standard. Traceability to a national standard (in the US, typically NIST) is common practice, not a requirement of the rule.
Defined acceptance limits and what happens when a device is found out of tolerance, including an impact assessment on product made since the last good calibration.

That last item is often the hardest. Finding a scale 2 percent off is the easy part. Deciding which batches it touched takes more work.

Automated, mechanical, and electronic equipment

Section 111.30 requires automated, mechanical, or electronic equipment to be routinely calibrated, inspected, or checked according to a written program designed to ensure proper performance, and requires controls so that only authorized personnel change the software or settings. If you run PLC-controlled blenders, label printers, or an ERP that decides component status, these controls apply to you. Shared logins on a packaging line computer are a recurring finding.

Equipment records

Section 111.35 requires records of written procedures for equipment and utensils, and documentation of calibration, maintenance, cleaning, and use as the rule specifies. Keep equipment logs that link each batch to the equipment used. When a complaint or recall happens, that link is how you find out what else shared the same vessel.

Subpart C versus Subpart D at a glance

Topic	Subpart C (Physical Plant and Grounds)	Subpart D (Equipment and Utensils)
Sections	111.15, 111.20, 111.23	111.25 through 111.35
Main focus	Building, grounds, utilities, sanitation	Machines, tools, instruments, software
Typical inspection finding	Pest activity, unprotected overhead fixtures, poor hand-wash access	Missing calibration, unclean product-contact surfaces, uncontrolled software access
Key written procedures	Cleaning, pest control	Cleaning, maintenance, calibration, automated equipment checks
Core records	Cleaning logs, pest control records (pesticide-use logs are good practice, not rule text)	Calibration records, cleaning and use logs, maintenance records
Best time to fix a problem	Before construction or lease signing	Before purchase and installation

How to run a pre-construction GMP facility review

If you are planning a new facility, a GMP review before construction is cheaper than correcting a finished building. This is the order to follow.

Start with the product list. Dosage forms, allergens, potent ingredients, and hygroscopic materials drive your separation and environmental needs. A powder-only operation and a softgel and liquid operation need different layouts.
Draw material, personnel, waste, and equipment flows on the floor plan. Any crossing of raw and finished flows is a design question to settle now.
Check room finishes against 111.20. Smooth, sealed, cleanable floors, walls, and ceilings, with coved joints, no exposed insulation, and sealed penetrations.
Plan the utilities. Potable water supply, backflow prevention, floor drains, compressed air quality if it contacts product, and HVAC with filtration suited to the dust load.
Place hand-wash sinks and restrooms where people will really use them. Before the entrance to production, not down a corridor.
Assign every status area. Receiving, quarantine, sampling, released storage, rejected storage, and finished goods hold.
Plan for pest exclusion. Door sweeps, sealed dock levelers, no gaps at utility entries, and exterior device locations.
Specify equipment with cleaning in mind. Accessible, cleanable, calibratable, and with controlled access on any software.

Facility and equipment compliance checklist

Use this as a working list during an internal walkthrough.

Grounds and building exterior

Perimeter clear of standing water, debris, and harborage
Doors and dock seals intact, with no daylight at the base
Dumpsters covered and positioned away from entrances

Building interior

Floors, walls, and ceilings smooth, intact, and cleanable
No leaks, condensation, or flaking material over open product
Light fixtures over exposed product are protected
Ventilation and dust control match the operations

Sanitation and utilities

Potable water source documented and tested as required
No cross-connections or back-siphonage risk
Hand-wash sinks stocked, working, and accessible
Restrooms clean and separated from production
Chemicals labeled and stored apart from components and packaging

Pest control

Device map and service logs current
Trend reports reviewed with corrective actions documented

Equipment and utensils

Product-contact surfaces nonreactive, nonabsorptive, and in good repair
Cleaning and maintenance procedures written and followed
Clean/in-use/dirty status clearly identified
Calibration program covers every critical instrument
Out-of-tolerance events trigger a product impact assessment
Software and automated equipment access limited to authorized users

Records

Cleaning, pest control, pesticide, calibration, and maintenance records complete
Retention aligned with 111.605

Common mistakes I see in facility reviews

Most of the findings that cost clients time come from a short list. Procedures written but not followed come first, where the SOP says weekly and the log shows monthly. Second is calibration programs that cover production scales but skip the thermometers in the warehouse or the balance in the lab. Third is a layout that grew by accretion, so a room that was designed for storage now holds blending, and nobody reassessed cross-contamination. Fourth is trusting the pest control vendor entirely, without anyone internal reading the reports.

None of these are hard to fix. They are hard to see from inside, because you walk past them every day. An outside set of eyes helps for that reason, whether yours is a consultant or a colleague from another site.

If you want a practical next step, take the checklist above, walk your building with a notepad and a flashlight, and write down every item you would be uncomfortable explaining to an investigator. That list is the start of your corrective action plan. If you want help with a pre-construction assessment or an existing-site gap analysis, our dietary supplement consulting team can work through it with you. For broader context on how this fits into a certification program, see our overview of GMP certification.

Last updated: 2026-10-02

Frequently Asked Questions

What is covered under 21 CFR 111 Subpart C?

Subpart C is titled Physical Plant and Grounds. It includes 111.15 (sanitation of the physical plant and grounds), 111.20 (design and construction of the physical plant), and 111.23 (records for these requirements). Equipment and utensils are covered separately in Subpart D, 111.27 through 111.35.

Does 21 CFR 111 require water to be potable?

Yes. Under 111.15, water that contacts components, dietary supplements, or product-contact surfaces must be potable and meet the EPA National Primary Drinking Water Regulations in 40 CFR part 141, or comparable standards. Keep documentation of your water source and any required testing.

How long do I have to keep facility cleaning and pest control records?

Under 21 CFR 111.605, keep records for one year past the shelf-life date of the product, or two years beyond the date of distribution of the last batch if no shelf-life date is assigned.

Do equipment calibration requirements apply to every instrument?

They apply to instruments and controls used in manufacturing or testing a component or dietary supplement (111.27(d)). In practice that covers scales, balances, thermometers, pH meters, and similar devices that affect product quality decisions. Automated equipment also needs routine calibration, inspection, or checking under 111.30.

Do I need a compliant facility if a contract manufacturer makes my supplements?

If you only outsource and never manufacture, package, label, or hold product yourself, Subpart C does not apply to your own premises. You still need to qualify your contractor and ensure it meets Part 111. If you store, relabel, or repackage, you are covered by the rule.