The USP supplement-specific microbial chapters: <2021> Microbial Enumeration Tests for Nutritional and Dietary Supplements (TAMC, TYMC), <2022> Microbiological Procedures for Absence of Specified Microorganisms (E. coli, Salmonella, S. aureus), and <2023> Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements (the limits table — e.g., aqueous formulations TAMC ≤10³ CFU/g, botanicals ≤10⁵ CFU/g).

Regulatory anchors

USP <2021>
USP <2022>
USP <2023>

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.