Lab

Objectionable organisms (non-sterile supplements)

TL;DR

USP <2022> requires absence of Escherichia coli, Salmonella spp. and Staphylococcus aureus in dietary supplements at defined sample sizes, with bile-tolerant Gram-negatives, Pseudomonas aeruginosa and Candida albicans added where dosage form or population warrants. Finding any specified organism — or an 'objectionable' organism (Burkholderia cepacia in liquid supplements, Cronobacter in infant-adjacent products) — is a stop-ship and triggers the 111.553 complaint/investigation flow.

Regulatory anchors

USP <2022>
USP <1112>

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.

Want to see Objectionable organisms (non-sterile supplements) in V5?

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