Who has to say yes before a supplement ships

A function with a veto

Somebody has to decide that a finished batch may go out the door. The dietary supplement rules name that role and load it with specific duties.

The term used is quality control personnel. The drug manufacturing rules use a different construct, a quality control unit, and set it up separately.

The supplement rules describe duties rather than an organizational box. What matters is what has to be approved, what has to be rejected, and what is written down either way.

The most useful part of the subpart is not the approval list. It is the short list of batches nobody is permitted to approve at all.

Written procedures before any decision

The subpart opens by requiring procedures, not judgment.

A maker must establish and follow "written procedures for the responsibilities of the quality control operations."

Those must include procedures "for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing."

So the two hardest calls in the subpart, what to do when something goes wrong and whether to rework it, have to have a written method behind them before they come up.

What has to be approved

The duty list is broad, and the first item covers almost everything upstream.

It begins with "Approving or rejecting all processes, specifications, written procedures, controls, tests, and examinations."

The same approval extends to "deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement."

Other items are smaller and easier to check for. Quality control personnel must review and approve the documentation behind a supplier qualification, and ensure that "required reserve samples are collected and held."

Five things that force a review

A material review is the formal look at something that did not go to plan. Five triggers are listed, and none of them is optional.

A specification not being met is the first. The second is when "A batch deviates from the master manufacturing record, including when any step established in the master manufacturing record is not completed."

The third covers surprises: "There is any unanticipated occurrence during the manufacturing operations that adulterates or may lead to adulteration of the component, dietary supplement, or packaging."

The fourth is instrument drift. It applies when "Calibration of an instrument or control suggests a problem that may have resulted in a failure to ensure the quality of a batch or batches of a dietary supplement." The fifth is the shortest line in the subpart: "A dietary supplement is returned."

Rejection is the default, and approval is the exception

The order of the sentence matters more than it looks.

Where a deviation or an unanticipated occurrence could lead to adulteration, quality control personnel "must reject the component, dietary supplement, packaging, or label."

Only then does the escape clause arrive: unless it "approves a treatment, an in-process adjustment, or reprocessing to correct the applicable deviation or occurrence."

The same structure governs a missed specification. Reject, unless an approved treatment, adjustment or reprocessing is applied. And the decision is documented by the person who made it, "at the time of performance."

The four batches that may not be released at all

This is the sharpest paragraph in the subpart, and it is written as a prohibition rather than a standard.

Quality control personnel "must not approve and release for distribution" four things. First, "Any batch of dietary supplement for which any component in the batch does not meet its identity specification."

Second, any batch "that does not meet all product specifications," reprocessed batches included. Third, any batch "that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration."

Fourth, any product received from a supplier for packaging or labeling where sufficient assurance is not provided to identify it and confirm it matches the purchase order. Identity failure is the one with no route around it.

Packaging, labeling and returns each get their own gate

Release is not one decision. It happens several times, at different stages.

Components, packaging and labels are approved and released from quarantine before they are used. Finished batches are approved and released, or rejected, for distribution.

Packaged and labeled product is a separate approval again, and repackaging and relabeling are each their own yes or no. The last item is "Approving for release, or rejecting, any packaged and labeled dietary supplement."

A returned supplement re-enters through the same door. Quality control personnel decide whether testing is needed, then approve or reject "any salvage and redistribution of any returned dietary supplement," and any reprocessing of it.

What the paperwork of a failure has to say

The record of a material review is the most informative document in the subpart, because it describes something that actually went wrong.

It has to identify the specific deviation or unanticipated occurrence, and carry a "Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence."

It has to evaluate whether the problem could lead to a quality failure, then record the "Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence."

It has to give an "Explanation of what you did with the component, dietary supplement, packaging, or label." Where anything rejected was reworked, it has to state "A scientifically valid reason for any reprocessing of a dietary supplement that is rejected."

Signatures and dates, at the time

Two small requirements do most of the work of making the rest checkable.

The records must carry the "Date that the review, approval, or rejection was performed" and the "Signature of the person performing the review, approval, or rejection."

The material review documentation has to be included in the appropriate batch production record, so a failure travels with the batch rather than in a separate file.

It also has to carry the signature of whoever made the disposition decision and of each qualified individual who provided information relevant to it.

What a reader can do with this

These are internal controls. None of them is visible from outside, and no part of the subpart requires any of it to be shown to a buyer.

What it does give a reader is a vocabulary for what a claim is missing. A statement that a product is tested does not say who reviewed the result or whether anyone had the authority to reject the batch.

The identity prohibition is the most useful single line to remember. If a component does not meet its identity specification, the batch may not be released, and no certificate cures that.

And these rules bind whoever is operating inside the dietary supplement category. Which category a given peptide product lawfully sits in is settled elsewhere on this site, not by anything above.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 111.123, What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations — the review and approval duties at (a), including approving and releasing or rejecting each finished batch for distribution at (a)(8), and the four categories that must not be approved and released for distribution at (b) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
2. Title 21 Code of Federal Regulations section 111.113, What quality control operations are required for a material review and disposition decision — the five triggers at (a), including a batch deviating from the master manufacturing record, an unanticipated occurrence, a calibration problem and a returned dietary supplement; the rejection default and its treatment, adjustment and reprocessing exceptions at (b); and the requirement to document the decision at the time of performance at (c) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
3. Title 21 Code of Federal Regulations section 111.140, Under this subpart F, what records must you make and keep — the written procedures at (b)(1), the dated and signed record of each review, approval or rejection at (b)(2), and the contents of the material review and disposition documentation at (b)(3), including the investigation, the corrective action, the explanation of what was done with the material, and the scientifically valid reason required for reprocessing rejected material — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
4. Title 21 Code of Federal Regulations section 111.105, What must quality control personnel do — the duty list, including approving or rejecting all processes, specifications, written procedures, controls, tests and examinations and any deviations from them at (a), reviewing and approving supplier qualification documentation at (b), and ensuring representative and reserve samples are collected at (f) and (g) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
5. Title 21 Code of Federal Regulations section 111.103, What are the requirements under this subpart F for written procedures — the requirement to establish and follow written procedures for the responsibilities of the quality control operations, including for conducting a material review and making a disposition decision and for approving or rejecting any reprocessing — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
6. Title 21 Code of Federal Regulations section 111.127, What quality control operations are required for packaging and labeling operations — the release from quarantine of received product at (b), the approval or rejection of repackaging at (f) and relabeling at (g), and the approval for release or rejection of any packaged and labeled dietary supplement at (h) — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007
7. Title 21 Code of Federal Regulations section 111.130, What quality control operations are required for returned dietary supplements — determining whether testing against product specifications is necessary, reviewing any results, approving or rejecting any salvage and redistribution, approving or rejecting any reprocessing, and determining whether a reprocessed returned supplement meets product specifications before release — Electronic Code of Federal Regulations, Office of the Federal Register, June 2007