Find out what the GMP registration audit will say about your plant, before the auditor does.
Send us your procedures, your qualification and validation packages, and a sample of your records. We read the whole scheme against all of it and tell you what is wrong, while there is still time to fix it.
FDA has written 23,440 observations against 21 CFR Part 111 across 2,507 supplement facilities. This scheme is the deepest of NSF’s supplement family, at 806 separate requirements against your operation.
NSF’s own requirements document, not the published standard.
This is what a supplement plant is audited against for NSF GMP registration. It covers bars, beverages, capsules, tablets, chews, softgels, gummies, drops, powders and sprays — amino acids, antioxidants, botanicals, fish oils, minerals, probiotics and vitamins.
People assume it is the federal rule with an auditor attached. It is not, and it is not the published ANSI standard either. It is NSF’s own requirements document, it is the largest of the family at 806 requirements applying to a facility, and it goes further into the operation than either.
Which means the two things that usually reassure a quality manager — a clean FDA history and a system built to Part 111 — tell you very little about how this audit will go.
Where it goes past what you are used to.
These are requirements written into the scheme in terms specific enough to fail against. A plant can be running well and still miss every one.
Incoming ingredients containing blends need a defined plan, and proprietary blends are prohibited outright. A batch record is not accepted in place of a certificate.
Blends used in Certified for Sport products have to be evaluated for banned substances, on top of everything else asked of an incoming ingredient.
Organoleptic or sensory identity testing is allowed only where the material can genuinely be identified that way — and chopped herbs are named as a case where it cannot.
Six topics named item by item: regulatory visits and inspection, food safety, personal hygiene and GMPs, safe food handling, pest control, and allergens.
Quality approves in-process controls and their justification, and approves specifications for raw materials, components, dietary ingredients, finished product and labeling. By name, in writing.
Any specification not met, any deviation from the master manufacturing record, and any unexpected production event that could lead to adulteration or mislabeling.
Notice how specific those are. A requirement written as “personnel shall be adequately trained” is arguable at an audit. A requirement that names six training topics is not — either they are in your training record or they are not, and the auditor can see which in under a minute.
NSF Dietary Supplements GMP System Assessment
We read the whole scheme against your system, tell you what is wrong with it, and tell you what to fix first.
And it is built to survive more than one auditor’s reading. This is not one person forming an opinion about your system. Every clause is examined against the documents meant to answer it, the records meant to prove it, the technical discipline behind it, and everything elsewhere in your system that could contradict it. Those reads are made independently and then reconciled into one answer, so forty findings that all come from one missing control arrive as one problem with every affected clause attached.
The registration auditor still decides. They simply have far less left to work out for themselves.
What this covers
- Whether what you have already written is good enough, requirement by requirement
- Which of your documents answers which requirement, and where inside it
- Whether your training records carry the topics this scheme names, or only the ones you thought of
- Whether quality actually owns the approvals the scheme puts on it, or someone else signs them
- Whether your incoming ingredient controls survive the blend rules
- What an auditor would write up, and the exact thing that would close it
- Which requirements no document can answer, because they are about the building or about what people do
- What to fix first, so you do not do the same work twice
What you get back
Every requirement of the scheme, in the order it puts them, marked answered or not. Where one of your documents answers it, we name the document and the page. Where nothing does, we say so and leave it blank.
Then the things that are not simply missing. What is there but does not go far enough. What one of your documents says that another one contradicts. What a procedure claims happens that your records do not show happening.
When forty findings all come from one missing procedure, we write it once and point the rest at it. You get the cause, not the pile.
And we tell you what to fix first. Fix the procedure before you rewrite a year of records to match it, not after. Every entry names the thing that is absent: the evidence, the decision, or the document.
You get the assessment, and a workbook listing every requirement against the document that answers it. Hand that one straight to the auditor.
What you send
Your procedures and controlled documents, your qualification and validation packages, and a sample of your records. We tell you which records and which dates, so you are not guessing and you are not uploading the whole file room.
Five business days, from the day we confirm we have everything. If something important is missing, you hear about it before the clock starts.
What this catches
A plant FDA has never had a problem with, read against this scheme. The company is made up. The rules underneath are real and you can look every one of them up.
A premix nobody can see inside.
A vitamin premix bought from a long-standing supplier, on the approved list for years, arriving with a certificate every lot.
The premix is a proprietary blend. The supplier will not break out what is in it, and the plant has never pushed, because the certificate has always been clean.
Clause G.4.4.2 requires a defined plan for incoming ingredients containing blends and prohibits proprietary blends outright. It also refuses batch records offered in place of a certificate. This is not a documentation gap that can be written around — the material itself is the finding, and closing it means going back to the supplier or changing it.
Identity confirmed by an experienced nose.
Incoming botanical identity confirmed organoleptically by a technician with twenty years on the job, signed and dated every time.
The material is chopped herb. Once it is cut, appearance and smell cannot tell one species from a cheaper adulterated one, and no instrumental method has ever been run on it.
Clause D.3.4.3 allows organoleptic or sensory identity testing only where the material can be positively identified that way, and names chopped herbs as a case where it cannot. Twenty years of experience is not the issue. The method cannot do what it is being asked to do, and the scheme says so specifically enough that there is nothing to argue.
Everyone is trained. On five of the six things.
A full training matrix, every operator signed off, refresher training current, records filed by person and by year.
Nothing in any new-hire session covers allergens, and nothing covers what to do when a regulator walks in. Both were left out because neither has ever come up.
Clause B.2.6.2 names the six topics new-hire GMP training must include: regulatory visits and inspection, food safety, personal hygiene and GMPs, safe food handling, pest control, and allergens. A requirement that lists its contents does not reward a good training program — it only asks whether the six are there. Two are not, and that is two findings out of an otherwise exemplary system.
Made-up company, real rules. We write these to show you the kind of thing that gets found, not to claim we found it. Your assessment is written against your own documents.
Price
What actually lands on your desk.
Four pieces of a finished assessment, opened here on the page. They come out of one written against a company we invented and read against NSF/ANSI 455-2, so you can see the shape of the thing before you pay for it. The company, its documents and its records do not exist. The requirements underneath are the real, published requirements of that standard.
Cascade Nutraceuticals is invented, and so are its documents and its records. They were written to show what the deliverable looks like, not to claim a catch. This specimen is an assessment against NSF/ANSI 455-2, not against the NSF Dietary Supplements GMP registration requirements: what changes from one scheme to the next is the standard behind the read, not the shape of what comes back. The requirements it is read against are the real, published requirements of NSF/ANSI 455-2. The standard’s own wording is not reproduced here; the clause identifiers and the federal citations are.
Every requirement of NSF/ANSI 455-2-2024, in the standard’s own clause order, with how it is answered, what that rests on and where inside it, and any finding against it. Five of the 695 rows.
The delivered workbook carries each requirement in the standard’s own wording. That wording is not ours to publish, so what you read below is our paraphrase of it. The clause identifiers and the federal citations are the standard’s own.
| Clause | The requirement, paraphrased | How it is answered | What that rests on, and where inside it | Finding |
|---|---|---|---|---|
| 4.1.1 | Whoever holds quality responsibility is not the post that runs operations. [21 CFR 111.12(b)] | Not found in what was supplied | Read against OOS-24-007 signature line, HR-TRN-01 “Competency by Function” first row, and LAB-2403-118 “Review & Approval”. Each of the three records the quality post and the operations or analyst post as one post; none establishes the separation the requirement calls for, and no organization chart, written assignment or delegation record was supplied. | 4.1.1 |
| 4.1.2 | The quality control work is identified, and it is carried out. [21 CFR 111.65] | Addressed, not settled from what was supplied | SOP-QC-012 §3.0 identifies the quality control duties, and OOS-24-007 and LAB-2403-118 record those duties being exercised on two lots. What was supplied does not reach whether quality control operations are implemented across manufacturing, packaging, labeling and holding: no batch production record, master manufacturing record or packaging and labeling record arrived, and none was declared as not existing. | No finding |
| 4.2.1 | Written procedures set out what quality control is responsible for. [21 CFR 111.87, 111.103, 111.105, 111.140(b)(1)] | Evidenced, no finding | SOP-QC-012 §3.0 Responsibilities. | No finding |
| 4.4.19 | Sewage and waste are plumbed away from the plant so they cannot reach contact surfaces, product, components or the water supply. [21 CFR 111.15(g)] | No document can answer it | Named at the front, under what documents could not answer. It turns on how the building is plumbed, which nothing you could send can settle, and no directed remote observation was purchased. It carries no finding. | No finding |
| 4.6.15 | Quality sets and approves the laboratory controls, including the sampling plans, how specifications are set, the test methods and the reference standards, and those methods are used to the criteria set for them. [21 CFR 111.315] | Evidenced, with a finding | LAB-2403-118, “Reference Standards & Reagents”; “System Suitability”. | 4.6.15 |
Eight dispositions run down that third column and every one of the 695 rows carries one. “Not found in what was supplied” says nothing was found in what was examined. It never says the control does not exist in your operation.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Every document supplied and what each one points at, built from the same references the drawn map in the assessment is built from. Fourteen documents arrived.
| Your document | What it references | Was the reference supplied | What points at it | How many point at it |
|---|---|---|---|---|
| SOP-QC-012 | FORM-QC-12A; FORM-QC-12B; SOP-QA-005; SOP-QC-002 | None supplied | OOS-24-007; HR-TRN-01 | 2 |
| MV-RHO/ASH-01 | ASSAY-RHO/ASH-01 Rev. 0; SOP-QC-002 | None supplied | Nothing points at it, and nothing has to | 0 |
| LAB-WS-007 | ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx; LAB-2403-118 | LAB-2403-118 supplied; ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx not supplied | Nothing points at it, and something has to | 0 |
| LAB-2403-118 | ASSAY-RHO/ASH-01 Rev. 0; QC-CALC-Rhodiola.xlsx | None supplied | LAB-WS-007 | 1 |
| OOS-24-007 | SOP-QC-012; CA-24-006 | SOP-QC-012 supplied; CA-24-006 not supplied | Nothing points at it, and nothing has to | 0 |
| QC-RSV-01 | Record-retention SOP | None supplied | CMP-LOG-AS | 1 |
| HR-TRN-01 | SOP-QC-012; Record-retention SOP | SOP-QC-012 supplied; Record-retention SOP not supplied | Nothing points at it, and something has to | 0 |
| SQF-RHO-03 | Supplier certificates of analysis; RM-RHO | None supplied | Nothing points at it, and nothing has to | 0 |
| REG-CLM-AS500 | AS-LBL Rev. 3 (2023); Ingredient supplier monographs | None supplied | Nothing points at it, and something has to | 0 |
| CMP-LOG-AS | QC-RSV-01 | Supplied | Nothing points at it, and something has to | 0 |
| PDC-AS700-01 | MBR-AS700; MF-AS700 rev A; SOP-VAL-02; CC-25-031 | None supplied | Nothing points at it, and nothing has to | 0 |
| CWC-SQCA-220 | CWC-SCA | Supplied | CWC-SCA | 1 |
| CWC-SCA | CWC-SQCA-220 | Supplied | CWC-SQCA-220 | 1 |
| NNRG-SQ-014 | No document named | No reference to check | Nothing points at it, and nothing has to | 0 |
Sixteen of the twenty-one documents this set names were not themselves supplied. They get their own sheet in the workbook, and that is the sheet worked first: it is the shortest route to closing the largest number of open rows on the requirement map.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Each finding is headed by the requirement it rests on and a short name for what is at issue. Findings sit in the standard’s own clause order, under the group stating what the assessment established about your record, and each one closes on the consequence that follows from it. This is one of eleven.
The delivered assessment heads the finding with the requirement in the standard’s own wording. That wording is not ours to publish, so the requirement line below is our paraphrase of it.
The release result reported for lot AS4830922 was not calculated against a reference standard that was within the expiry the record itself states for it.
LAB-2403-118, “Reference Standards & Reagents” table: the Rosavin reference standard, lot R04219, carries an expiry of 30 NOV 2023. The same report records the run as acquired 11 MAR 2024 and the reportable result as calculated from the bracketing Rosavin standard mean.
LAB-WS-007 for the same lot repeats the standard lot as R04219 and the reference-standard expiry as 11/30/23, and records the reportable value as transcribed from a spreadsheet named in the worksheet rather than calculated on the worksheet.
LAB-2403-118, “System Suitability”: the replicate-standard %RSD is entered as “not calculated” and the suitability acceptance criterion is entered as “per method file”, so the record carries no criterion the standard was judged against on the day of the run.
The reference standard is what the result is measured against; where its expiry has passed, the number the lot was released on has nothing established behind it.
What was supplied does not establish a supportable result for the release of lot AS4830922.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
One row per finding, in the standard’s own clause order. Eleven rows. This is one of them.
The delivered register carries the requirement in the standard’s own wording. That wording is not ours to publish, so the requirement cell below, and the one place another cell restates a clause, are our paraphrase.
QC-RSV-01, “Reserve Sample Records”, the row for lot AS4815602 (manufactured 11/2023, expiring 11/2026): the units retained column reads “none on file”, and the container, retain-until, storage and logged-by columns are each empty.
QC-RSV-01 is the only record supplied that addresses reserve sample collection; its header states the retention policy as written rather than referring to a procedure, and names no procedure that governs it.
Everything under “Yours to fill” is yours, and it is delivered empty. No owner is assigned, no date is set and no status is pre-filled, because each of those needs to know what your operation can absorb and nothing in this assessment knows that. There is no formula in the file, so you can add columns, add rows and set your own filters without breaking it.
Constructed specimen. Cascade Nutraceuticals, its documents and its records do not exist and were written to show the deliverable. The requirements are the real, published requirements of NSF/ANSI 455-2. Nothing here is a finding against any company.
Straight answers.
You never see my plant. What is the point?
We read every requirement. The ones that are about the building, or about what people physically do, get named as exactly that and get no finding. The rest can be answered from what you send — 568 of the 806 that apply to you. The walkthrough exists if you want the remainder answered too.
How is this different from the 455-2 assessment?
Different document, different audit. 455-2 is the published ANSI standard; this is NSF’s own GMP registration requirements document, and it is larger — 806 requirements against your facility rather than 622. Which one you need is set by whoever asked you to register, not by preference. If you are not sure, that is worth settling before you buy either.
We pass FDA inspections. Why would we need this?
Because this scheme asks for things in terms specific enough to fail against that federal law leaves general. Six named training topics. A prohibition on proprietary blends. A restriction on when organoleptic identity testing counts. FDA has never asked you any of those questions in those words.
Can I just download the checklist?
You can, and it will tell you the clauses exist. It will not open your training matrix and tell you two of the six named topics are missing. Having a document is not the same as having one that answers the requirement.
What if you find something we cannot fix in time?
Then you know before the auditor does, and you get to decide what to do about it. That is the point of the name. We lay out what is there and what would close it; which risks you carry into the audit is yours to choose.
Is what I send confidential?
Yes. What you send is used only to do the work you paid for, seen only by the people doing it, never sold, and never used to train any public AI model. It is kept only as long as we need it. Section 4 of the privacy policy, linked at the foot of every page.
This page is about one scheme. You may need something else.
An assessment reads your whole system and tells you what is wrong with it. If that is not the job in front of you, here is where the rest of the work goes.
Regulatory work product, not legal advice. An assessment is prepared from the records you submit and is not legal counsel, not a registration decision, and not a prediction of any audit outcome — those are decided by the certification body. It is a read of documents: no site visit is performed, and every requirement that depends on physical conditions or observed practice is named as outside the read and gets no finding unless the optional facility walkthrough is purchased, in which case each such finding states what was shown, by whom, and on what date. It relies on what you supplied and on your own declarations about your operation, none of it independently verified. Clause references are quoted from NSF’s Dietary Supplements GMP manufacturing facility registration requirements. All companies and products shown in examples are constructed; any resemblance to a real company or product is coincidental. Regulatory Options is not affiliated with or endorsed by NSF.