$8,500 gap assessment

OTC Monograph Drugs

OTC Drug
GMP Consulting

We help cosmetic, personal care and supplement manufacturers that have started making OTC drugs, such as sunscreens, acne treatments, antiperspirants and skin protectants, run a quality system that meets drug GMP under 21 CFR Parts 210 and 211, and pass an FDA inspection as a drug manufacturer.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
$8,500
Published price
Gap to ready
Phased
NSF 455-4
Benchmarked
Jared Clark, OTC Drug GMP Consulting consultant

What you get

A drug quality system, not a cosmetic one with a new label

Moving from cosmetics into OTC drugs changes the rules for everything from incoming components to release. The site usually has good people and good bones. What it lacks is the drug-GMP layer. This is how we add it.

A gap assessment

An on-site review against 21 CFR 210 and 211, benchmarked against NSF/ANSI 455-4 for OTC drugs, with every finding ranked and a plan to close it.

The drug-GMP layer

The procedures cosmetics do not need: component testing and supplier qualification, master and batch production records, stability, laboratory controls, investigations, change control and annual product review.

Validation

Process, cleaning, water system and equipment qualification, and computer system validation for the software the quality system runs on, using risk-based approaches.

Inspection readiness

Registration and listing checked, staff trained, and a mock FDA inspection before the real one, so the first inspection is not the test.

How It Runs

Three steps

1

Assess

A gap assessment on site, usually two days, ending in a written report and a phased plan. You can stop there and do the work yourselves.

2

Implement

If you want help, we build the procedures, validation and training alongside your team, in your document control system.

3

Verify

An internal audit and a mock FDA inspection to confirm the system works, and a readiness statement against NSF/ANSI 455-4 if certification is on your roadmap.

Scope

What changes when you make an OTC drug

OTC monograph drugs are drugs, and the facility that makes them must follow drug GMP, whatever else it makes. In practice that means a quality unit with real authority over release, testing of every component lot (identity at minimum) or a validated basis for relying on supplier certificates, written and validated processes, stability data supporting expiry dating, laboratory controls, documented investigations of every deviation and out-of-specification result, and drug establishment registration and product listing with FDA.

The risks we see most often at sites crossing over from cosmetics are shared equipment without validated cleaning, purified water systems that were never qualified, change control configured for cosmetics, suppliers with no qualification at all, and a team that thinks of drug GMP as something that applies a few days a year. The last one is the hardest to fix and the most important.

Related: cosmetics GMP, FDA records requests and mock FDA inspections.

A good fit

  • You make cosmetics or personal care products and have added, or plan to add, an OTC drug.
  • FDA has asked for records or inspected you as a drug manufacturer and the gaps were plain.
  • A retailer or partner is asking for evidence of drug GMP, or for NSF/ANSI 455-4.

Not the right service

  • –You need a new drug application or a non-monograph product approved. That is a regulatory submissions project, outside what we do.

Price And Terms

Gap assessment $8,500, fixed; you commit one phase at a time

Every engagement is priced in writing after a free 30-minute call and before any work starts. On-site work is scheduled in full days; travel from Salt Lake City is billed at cost, with no markup, after the visit. You own every report and record we produce.

The gap assessment is a fixed fee on its own. Implementation and verification are estimated in the gap report and quoted only if you choose to go ahead.

Frequently asked questions

What does an OTC drug GMP gap assessment cost?

$8,500, fixed, for a two-day on-site assessment against 21 CFR Parts 210 and 211 with a written report and phased plan, plus travel at cost. Implementation and verification are estimated in the report and quoted only if you choose to go ahead.

Do cosmetic manufacturers need drug GMP to make OTC products?

Yes. A product that meets the definition of a drug, such as a sunscreen, an acne treatment with salicylic acid or benzoyl peroxide, or an antiperspirant, must be made under drug GMP in 21 CFR Parts 210 and 211, even if everything else on the site is a cosmetic.

What is NSF/ANSI 455-4?

The NSF/ANSI 455 family sets GMP audit standards for supplements (455-2), cosmetics (455-3) and OTC drugs (455-4). Certification to 455-4 is voluntary and is often requested by retailers. It is useful evidence, but FDA inspects against the regulations, not the NSF standard.

Do OTC drug manufacturers have to register with FDA?

Yes. Establishments that manufacture drugs must register with FDA and list their products under 21 CFR Part 207, and keep both current. Registration problems are among the first things an investigator notices.

How long does it take to bring a cosmetic site up to drug GMP?

For a site with a working ISO 9001 or cosmetic GMP system, typically four to eight months from gap assessment to inspection-ready, depending on how much validation is needed. The gap assessment gives a firm estimate for your site.

Your Consultant

Who does the work

Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.

Related Services

Often paired with this one

FDA Remote Regulatory Assessments

Help answering an FDA records request or remote assessment, and closing the gaps it exposes.

Mock FDA Inspection

We inspect your site the way FDA would and give you a mock Form 483 while there is time to fix it.

Supplier Audits

On-site audits of your contract manufacturers and ingredient suppliers, with a signed report for your supplier file.

Start with the gap assessment

Book a free 30-minute call. Tell us what you make, what you plan to make and whether FDA has been in touch, and we will propose the first phase in writing.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting