Microbiome supplements span probiotics (live, ISAPP Hill 2014), prebiotics (substrate selectively utilised by host microorganisms with benefit, ISAPP Gibson 2017), synbiotics (probiotic + prebiotic combination with benefit, ISAPP Swanson 2020 with complementary and synergistic sub-types), postbiotics (preparation of inanimate microorganisms or components with benefit, ISAPP Salminen 2021 — excludes purified metabolites without microbial components, purified components without consensus benefit and 'killed probiotic' marketing without measured benefit on the inanimate preparation) and live biotherapeutic products (drug-regulated). Strain-level identity by whole-genome sequencing is the regulatory expectation across FDA, EFSA QPS, Health Canada NHPID, Korea MFDS HFF and Japan FFC — replacing species-level identification because effects are strain-specific. Deposit at recognised culture collection (ATCC, DSMZ, NCIMB, JCM, KCCM, CGMCC) with master cell bank and working cell bank chain of custody. WGS enables antimicrobial resistance gene screening (required EFSA QPS), virulence factor and plasmid characterisation. Stability discipline differs — CFU retention with overage justification and ISO 19344 flow cytometry or USP <61> plate count for probiotics; bioactive marker retention for postbiotics; substrate retention by HPLC for prebiotics (FOS, GOS, inulin, HMOs). EFSA Article 13 has authorised no general 'probiotic' health claim — EU market positioning uses structure/function statements rather than authorised health claims, with cross-market differential copy for US/Japan/Korea.

Regulatory anchors

ISAPP Consensus Definitions (Hill 2014, Gibson 2017, Swanson 2020, Salminen 2021)
ISO 19344
USP <61>
EFSA QPS

Industries that live with this

Dietary Supplements

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.

From the first pull to a signed CoA in your customer's hands.

One connected QC loop. The analyst runs the sample on the kiosk; the result lands on the chart; an out-of-spec opens its own investigation, spawns a CAPA, holds the batch and routes the disposition; the released lot's Certificate of Analysis is built from real values, signed under §11.50, and delivered to the customer portal with every view logged. No spreadsheets. No retyping. No quiet edits.

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.

Labels — designed, approved, printed and audited in one place.

Most regulated manufacturers run a label tool (NiceLabel, Loftware, BarTender) bolted next to their QMS — versions drift, reprints aren't audited, and 211.122 / 111.130 / 820.120 findings follow. V5 puts the designer, the approval workflow, the print agent and the reprint audit trail in one place — the same place that holds the BMR.