Supplement and cosmetics GMP · training path
Batch records an auditor can follow. Specs you test to. Deviations you can close.When the auditor asks for the batch record, be the one who already knows it's right.A COA doesn't verify a dietary ingredient. Know what 21 CFR 111 asks before FDA does.
The path takes you through batch records, specifications and testing under 21 CFR 111, the ISO 22716 guideline for cosmetics, and investigating deviations and closing CAPA the GMP way. Each course is on the way, with its own waitlist.
For QA staff at dietary supplement and cosmetics makers.
Be first in. Join the waitlist for this path.
Your signup tells us which of these courses to finish first. One email when the first one opens.
- 3 courses planned
- Nothing to pay to join
- We'll email you when one opens
Sound familiar?
The batch record says one thing. The floor did another.
The supplier's COA says it's ashwagandha. Isn't that enough?
Not for a dietary ingredient. 21 CFR 111.75 calls for at least one appropriate test or examination to verify its identity, and a COA can stand in only for other components, from a supplier you've qualified. Dietary Supplement GMP (21 CFR 111) is on the way, for specifications and testing.
Our batch record is the recipe with a date and initials.
A recipe isn't a batch record. 21 CFR 111 wants a batch production record every time you make a batch, documented as each step is done, showing quality control approved and released it, or rejected it. Dietary Supplement GMP (21 CFR 111) is on the way, for batch records.
We make cosmetics. There's no FDA GMP rule for us.
MoCRA changed the direction. It requires FDA to set GMP regulations for cosmetic facilities, and FDA's draft guidance on cosmetic GMP already drew on ISO 22716. Cosmetics GMP (ISO 22716) is on the way, for the guideline cosmetics makers are audited to.
It ran a little out of spec, so we adjusted and kept going.
When a batch misses a spec or strays from the master manufacturing record, 21 CFR 111.113 calls for a material review. Quality control makes the disposition call and documents it at the time. Deviations and CAPA in a GMP Plant is on the way, for investigating deviations and closing CAPA the GMP way.
What it's for
Be the one the plant trusts when the auditor asks.
The one who reads a batch record like an auditor
Components, specs, each step as it was done, quality control's release. When you can see the gap before an investigator or a customer's auditor does, the hard batches start coming to you.
A straight answer when purchasing pushes back
When someone wants to skip the identity test because the COA looks fine, you can say no and show the rule behind it. That's the kind of call owners remember.
Hard to replace
Plenty of people can fill in a batch record. Fewer can tell when one won't hold up, and fix it before an auditor finds it. That's the skill that comes up at review time.
No course can promise you a raise or a title. What these courses are for is the skill, and the work to show for it.
Why it matters
Nearly half the supplement plants FDA inspected got a 483.
Of 800 dietary supplement manufacturing facilities FDA inspected in fiscal 2025, in the US and abroad, 49.1% received a Form 483 indicating noncompliance with current good manufacturing practices.
Source: ConsumerLab.com, FDA fiscal 2025 inspection results obtained under FOIA, Sep 10, 2026
FDA's compliance program for supplement inspections lists the GMP violations it uses to recommend regulatory action. No written batch records. No master manufacturing record. No identity testing on dietary ingredients. No finished product release specs. Every one of those lands on QA's desk.
Cosmetics are moving the same way. MoCRA requires FDA to set GMP regulations for facilities that manufacture cosmetics, and ISO 22716 is the international guideline for producing, controlling, storing and shipping them. In either kind of plant, it's QA that gets asked to show the record.
The full path
The route through supplement and cosmetics GMP
Start with the GMP your plant makes product under, 21 CFR 111 for supplements or ISO 22716 for cosmetics, then Deviations and CAPA for when a batch doesn't go to plan. Each course stands on its own.
The planned route
These courses are on the way, so join the waitlist for the ones you need and we'll email you when yours opens.
-
On the way
Dietary Supplement GMP (21 CFR 111)
Batch records, specifications and testing.
-
On the way
Cosmetics GMP (ISO 22716)
The guideline cosmetics makers are audited to.
-
On the way
Deviations and CAPA in a GMP Plant
Investigate deviations and close CAPA the GMP way.
Who's behind it
Taught from the audit side and the plant floor.
Will Trikha
Founder and CEO, QMS Learning · Third-party registrar auditor
Will Trikha is a third-party registrar auditor with more than 20 years in aerospace and quality. He also runs a nutraceutical contract manufacturer, so he lives with GMP from the manufacturer's side.
He's COO of PTX Defense, an AS9100D-certified aerospace manufacturer, and founder of QMS Leader, a consulting firm that implements quality management systems for manufacturers. Different products, same test: someone else has to be able to follow the record and reach the same answer.
While you wait
- Lesson 1 of every live course is free. Browse the live courses.
- Check a certificate. Every certificate can be confirmed at academy.qmslearning.com/verify.
- Training a team? Email will@qmslearning.com.
Questions
Straight answers.
Do I have to take them all?
No. Each course stands on its own, with its own price, so join the waitlist only for the ones your plant needs.
When do the courses open?
We don't give dates until a course is ready. Join the waitlist on any course and we'll email you when it opens. Signups help decide what we build next.
Is this an accredited certification?
No. QMS Learning courses end with a QMS Learning certificate that anyone can check at academy.qmslearning.com/verify. It isn't an accredited certification, and it doesn't certify your plant.
Is 21 CFR 111 a law or a guideline?
It's a federal regulation. 21 CFR Part 111 sets current good manufacturing practice for manufacturing, packaging, labeling and holding dietary supplements, and FDA inspects manufacturers to it, in the US and abroad. ISO 22716 is a guideline.
Is ISO 22716 still current?
Yes. ISO 22716:2007 is still the published edition, and ISO last reviewed and confirmed it in 2022. It covers the quality side of producing, controlling, storing and shipping cosmetics, not worker safety or the environment.
When will these courses open?
We don't promise dates. The waitlist tells us which courses to finish first, and we email you once when a course you joined opens. Every email has an unsubscribe link.
The GMP for Supplements and Cosmetics path
Join the waitlist for the GMP course your plant needs.
- Dietary Supplement GMP (21 CFR 111)On the way
- Cosmetics GMP (ISO 22716)On the way
- Deviations and CAPA in a GMP PlantOn the way
One email when the first course on this path opens. Nothing to pay to join.