[ lab notes ]
< the batch records >
what a batch has to clear before it ships
a batch is not finished when it is made. it is finished when it is verified.
this blog is called batch records because batch production record is a real, legally defined document — and what has to be in it is written down.
dietary supplements made or sold in the united states fall under 21 CFR Part 111, the fda's current good manufacturing practice regulation for supplements. it is not a certification anyone buys. it is a federal requirement, and it is specific.
the parts that decide whether what is in the tub matches what is on the label:
01. incoming identity — §111.75(a)(1)(i): at least one appropriate test or examination to verify the identity of every component that is a dietary ingredient, before it is used. every ingredient. every time. the only way out is a petition the fda has to grant, and it has to prove no material diminution of assurance versus testing 100%.1
02. other components — §111.75(a)(2): identity confirmed and specifications verified, either by your own testing or by relying on a supplier's certificate of analysis — but only if you qualified that supplier first and periodically re-confirm their results yourself. a COA is a starting point, not a finish line.1
03. in-process — §111.75(b): monitoring at the points in the run where a deviation could cause a failure. this is where blend uniformity lives. a scoop from the top of a drum and a scoop from the bottom have to be the same scoop.
04. finished batch — §111.75(c): verify the finished batch, by statistical sampling or by testing 100%, for identity, purity, strength, composition, and limits on contamination.1
05. methods — §111.75(h): the methods used must be appropriate and scientifically valid. you do not get to invent a test that always passes.
§111.260 lists what has to be captured for every single batch.2 the short version: the batch and lot numbers. the equipment and processing lines used. the dates and times that equipment was cleaned and sanitised. a unique identifier for every component. the identity and weight or measure of each component. the actual yield against the theoretical yield. the results of in-process monitoring. the results of every test. documentation that the finished product met specification. dates, steps, and the initials of every person who performed them. label reconciliation. and the quality control decision to approve or reject.
that last one is the whole thing. a named person has to put their initials on this batch is fit to ship, and that record has to still exist afterward.
this phrase gets used for two completely different claims.
(—) the weak version — a third party audits the facility. that certifies a process, not a product. the tub you are holding was never assayed.
(+) the strong version — the finished product, from that batch, is assayed by a laboratory with no financial stake in the result passing.
the programs are not interchangeable either. USP Verified and NSF focus on identity, potency and contaminants. NSF Certified for Sport and Informed Sport add banned-substance screening for competing athletes. none of them is implied by a gmp facility audit, and none of them is a synonym for the others.
on contaminants there are published numbers to hold anyone to. USP general chapter <2232> sets permitted daily exposure limits for elemental contaminants in dietary supplements:3
(+) arsenic (inorganic) [x] 15 µg/day
(+) cadmium [x] 5 µg/day
(+) lead [x] 10 µg/day
(+) mercury, total [x] 15 µg/day
(+) methylmercury, as Hg [x] 2 µg/day
lot_no is printed on every tub. it is not decoration and it is not a design flourish.
it is the index. every requirement above attaches to a specific batch, and the record of that batch — the weights, the yields, the test results, the signature — is required by law to exist and to be retrievable by that number.
a brand that prints a lot number is a brand that can be asked a specific question about a specific tub. that is the point of putting it there.
(+) the batch is the unit of trust
[x] identity [y] potency [z] purity
[1] eCFR — 21 CFR §111.75, What must you do to determine whether specifications are met? https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-E/section-111.75
[2] eCFR — 21 CFR Part 111 Subpart I, Requirements for the Batch Production Record (§§111.255–111.260). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-I
[3] USP General Chapter <2232>, Elemental Contaminants in Dietary Supplements, Table 1. https://www.uspnf.com/notices/general-chapter-elemental-contaminants-dietary-supplements
[4] FDA — Small Entity Compliance Guide: Current Good Manufacturing Practice for Dietary Supplements. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling