Who Can Prepare an OTC Drug Facility for FDA Inspection

Who can prepare an OTC drug manufacturing facility for an FDA inspection?

Your own quality staff prepare an OTC drug facility for an FDA inspection, usually with an outside drug GMP consultant helping them. An OTC drug is an over-the-counter drug, meaning one sold without a prescription, such as a sunscreen, an acne treatment, a hand sanitizer or an antiperspirant. GMP stands for good manufacturing practice, the rules for how a product has to be made and documented. The people who do the work are inside your company, and the consultant's job is to help them do it well.

I have put the short answer first because many owners expect the opposite. The regulation explains why. The rest of this article walks through who is responsible, what a consultant can legitimately do, what preparation covers, and what you can do today.

What rules does FDA inspect an OTC drug plant against?

FDA inspects an OTC drug plant against drug GMP, which is 21 CFR Parts 210 and 211. Part 210 and Part 211 together are the minimum current good manufacturing practice for finished pharmaceuticals, and 21 CFR 210.1(b) says a drug that was not made in compliance with them is considered adulterated under the Federal Food, Drug, and Cosmetic Act. Adulterated has a legal meaning here: FDA can treat the product as unlawful to sell, whatever the product looks like or how well it works.

Part 211 is the rule for making finished drugs, which means products in the form a customer actually uses. It applies to a sunscreen lotion, an acne gel, a hand sanitizer or an antiperspirant in the same way it applies to a tablet. The word "over-the-counter" sounds lighter than "prescription," but the manufacturing rule does not get lighter with it. Part 211 applies to finished OTC drugs whether they are marketed under an OTC monograph or an approved application.

The surprise tends to hit hardest for companies that started in cosmetics or dietary supplements. The systems those companies know differ from Part 211. 21 CFR Part 111, FDA's manufacturing rule for supplements, has its own quality control and batch record requirements, but they are written for supplements, not drugs. Cosmetics have not had a Part 211-style federal GMP mandate, and a voluntary standard such as ISO 22716 is a useful starting point for a cosmetic maker but is not drug GMP. An investigator at an OTC plant inspects against Part 211. Owners can find that out late, sometimes when the investigator is already in the building.

Who is legally responsible for compliance?

The company is responsible, and inside the company, the quality unit carries that responsibility. 21 CFR 211.22 calls it the "quality control unit" and gives it the responsibility and authority to approve or reject components, drug product containers, labeling, in-process materials and finished drugs. It also makes the unit responsible for reviewing production records and for approving procedures and investigations, and it says the unit's responsibilities must be written down.

In plain words, the quality unit is the person or team who approves procedures and investigations and who can say "this batch does not ship." That decision belongs to your company. An outside consultant can't take it over.

If you run a small company, you may be the quality unit. That is allowed, and it is common. What matters is that someone has the authority and the written responsibility, and that you can show an investigator who it is. It also means that if you are the owner, the production manager and the quality unit all at once, you will want to be honest with yourself about whether one person can really review batch records and also approve the release of those same batches. A consultant can help you think through that arrangement.

What does a consultant have to be qualified to do?

21 CFR 211.34 is the section that covers consultants directly. It says consultants who advise on the manufacture, processing, packing or holding of drug products must have sufficient education, training and experience, or any combination of those, to advise on the subject they were retained for. It also requires you to keep records stating the name, address and qualifications of any consultant and the type of service they provide.

So there are two things to do. First, choose someone whose background matches the subject. Second, keep a file on that person: a résumé or qualification summary, the dates they worked with you, and what they did. A statement of work and a short summary of each visit usually covers it. If an investigator asks "who has advised you on drug manufacturing," you should be able to hand over that file the same day.

What should you look for in a consultant?

In my view, the first thing to look for is drug manufacturing experience, ideally OTC. A consultant whose whole career is in food safety, cosmetics or supplements may be very good at what they do, and still miss what an OTC investigator looks for. The reverse is also true: someone with only large-scale prescription manufacturing experience may over-build a system for a small OTC site. Ask a candidate which OTC dosage forms they have worked on (topical, liquid, antiperspirant stick, sanitizer), and ask them to describe how they handled the validation and stability questions below.

Also ask what they will and won't do. A good consultant will tell you plainly that the quality unit decisions stay with you.

Who does what? Your staff versus the consultant

What does preparation actually cover?

Preparation starts with a gap assessment. Someone reads your procedures and records against Parts 210 and 211 and writes down what is missing. It can be done by your quality staff, by a consultant, or by both together. The written list of gaps is what turns a vague worry into a work plan with owners and dates.

What gaps show up most often at OTC sites?

These are the topics I would check first, especially for companies that grew up in cosmetics or supplements. This is a practitioner's judgment, not a count from FDA inspection data.

Process validation. This is proof that your process makes the same product every time. 21 CFR 211.100(a) requires written procedures for production and process control designed to assure that drug products have the identity, strength, quality and purity they are supposed to have. FDA's guidance Process Validation: General Principles and Practices (January 2011) describes the lifecycle approach FDA expects. For each product, be ready to show data from actual batches that proves the process works.

Cleaning validation. This is proof that your cleaning removes the last product from the equipment. 21 CFR 211.67 requires that equipment and utensils be cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the quality of the drug. A written cleaning procedure is the start. An investigator will also want evidence that the procedure works, such as swab or rinse results.

A stability program. This is the written testing plan that supports your expiration date. 21 CFR 211.166 requires a written testing program designed to assess the stability characteristics of drug products, and the results are used to set storage conditions and expiration dates. An expiration date with no data behind it is a gap an investigator can cite under 211.166.

Equipment qualification. This is documented proof that each machine was installed correctly and works as intended. Part 211 does not use the word "qualification," but 21 CFR 211.63 requires equipment to be of appropriate design, adequate size and suitably located for its use, and 211.68 covers calibration and inspection. FDA's Process Validation: General Principles and Practices guidance treats qualification of equipment and utilities as part of process design and validation, so expect an investigator to ask for the paper trail that shows your mixer, filler or tank does what you say it does.

Batch records. 21 CFR 211.188 requires batch production and control records that document each significant step. In practice, that means every weight, equipment ID and in-process test is captured, signed and dated. Records written for a cosmetic operation often leave out some of those entries.

Does registration and drug listing matter?

Yes, and it gets checked. Registration and drug listing are your facility's and your products' entry in FDA's database, and the requirements come from section 510 of the Federal Food, Drug, and Cosmetic Act and are in 21 CFR Part 207. Facilities making OTC monograph drugs are also covered by the user fee framework the CARES Act created (OMUFA), which includes annual facility fees, so confirm your fee status with FDA. You can look up your own listing, and you should do that before anyone else does. An unlisted product is a problem before the investigator touches a single record. If your facility's registration is missing or your products are not listed, fix that first and then work through the technical gaps.

What can a consultant do before and during the inspection?

A consultant can run a mock inspection. That means playing the investigator, asking for records the way FDA would, and writing up findings like a Form 483. A Form 483 is the list of observations an investigator leaves behind at the end of an inspection, and FDA explains how it works on its page FDA Form 483 Frequently Asked Questions. A mock inspection is often the first time the team feels what it is like to be asked "show me" and have to find the record in a few minutes.

A consultant can also coach the people who escort the investigator, pull records or work the line, so each can explain what they do in their own words. Coaching is not scripting. Investigators can tell the difference between an operator who understands the batch record and one who memorized an answer, and the honest answer ("I check the weight against the batch record and sign here") is the one that holds up.

During the real inspection, a consultant can help staff the back room. That is where someone pulls records for the investigator out of sight of the floor, so the escort can keep walking and the records arrive promptly and in order.

What a consultant can't do is take over compliance. The company stays responsible. FDA decides what it observes and how it classifies an inspection, so no consultant can promise an outcome.

A practical order of work for a first-time OTC drug site

If your site is meeting drug GMP for the first time, this is the order I would suggest.

1. Confirm registration and listing. Look yourself up in FDA's database and make sure each product is listed.
2. Name your quality unit in writing. Decide who holds the 211.22 responsibilities, including who approves procedures and investigations.
3. Choose a qualified consultant and open the 211.34 file. Get the qualification record and a written scope of work before the first visit.
4. Do a gap assessment against Parts 210 and 211. Have the findings written down, one line per gap.
5. Assign an owner and a date to each gap. Start with process validation, cleaning validation and stability, since those take the longest.
6. Run a mock inspection. Do it once the main records exist, so you are testing real documents and not an empty binder.
7. Prepare the escorts and the back room. Practice pulling records quickly and answering plainly.

Some gaps take months, not weeks, because validation and stability data need real batches and real time on the shelf. As a rough guide, real-time stability data covering a two-year expiration date take up to two years to collect in full, while accelerated studies of about six months, as described in ICH Q1A(R2), may support a provisional date. Validation timing depends on how many products and batches you run. I have not given cost ranges because they vary too much by site and product. That is why starting early matters more than any single document.

What can you do today?

Pick one product. Ask whoever handles quality, or do it yourself if that's you, to show you three things: its process validation, its cleaning validation and its stability program. If one of the three is missing, start with that one and write down who will own it.

That small exercise tells you more about your readiness than a long checklist would, because it is the same thing an investigator will do. If all three are there, pick the next product and repeat. If you want a second set of eyes on the answers, you can contact Certify Consulting for a free call, or read more about GMP certification and compliance support.

At Certify Consulting, we help OTC drug makers with a gap assessment against 21 CFR 210 and 211, with the procedures, validation and records it turns up, and with FDA inspection preparation. That includes sites meeting drug GMP for the first time.

Start this week: name your quality unit in writing, confirm your products are listed with FDA, and pick the first product for the three-document check above.

Last updated: 2026-11-12

Frequently Asked Questions

Who can prepare an OTC drug manufacturing facility for an FDA inspection?

Your own quality staff prepare the facility, usually with an outside drug GMP consultant helping. Under 21 CFR 211.22 the quality unit is responsible for compliance, so a consultant can advise and coach but cannot take that responsibility over.

What rules does FDA inspect an OTC drug facility against?

Drug GMP, which is 21 CFR Parts 210 and 211. Part 211 covers finished drugs and applies to OTC products such as sunscreens, acne treatments, hand sanitizers and antiperspirants. It is not the cosmetic standard or the dietary supplement rule in 21 CFR Part 111.

What does 21 CFR 211.34 say about consultants?

It requires consultants who advise on drug manufacturing to have sufficient education, training and experience for the subject they advise on, and it requires you to keep records of the consultant's name, address, qualifications and the type of service provided.

What are the most common gaps at OTC drug sites?

Process validation, cleaning validation, a stability program supporting the expiration date, equipment qualification records and complete batch records. Registration and drug listing in FDA's database are also checked.

Can a consultant guarantee a clean FDA inspection?

No. The company stays responsible for compliance and FDA decides what it observes. A consultant can run a mock inspection, coach staff and support the back room, but anyone who promises an outcome should be treated with caution.