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 records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

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 scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

USP <2021>/<2022>/<2023> microbial limits

Next step

USP <2021>/<2022>/<2023> microbial limits

Next step