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TAMC/TYMC specification setting

In short

Total Aerobic Microbial Count (TAMC) and Total Yeasts & Moulds Count (TYMC) per USP <2021> are the routine microbial counts for non-sterile supplements. Spec is set from USP <2023> dosage-form table (e.g., raw botanicals ≤10⁵ CFU/g TAMC, ≤10³ CFU/g TYMC; finished aqueous ≤10³/...

Total Aerobic Microbial Count (TAMC) and Total Yeasts & Moulds Count (TYMC) per USP <2021> are the routine microbial counts for non-sterile supplements. Spec is set from USP <2023> dosage-form table (e.g., raw botanicals ≤10⁵ CFU/g TAMC, ≤10³ CFU/g TYMC; finished aqueous ≤10³/10²; oral solid non-aqueous ≤10⁴/10²) and tightened where in-process trend data warrants — not just copied from the USP ceiling.

Regulatory anchors
  • USP <2021>
  • 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.
Related terms
USP <2021>/<2022>/<2023> microbial limits
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