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Microbiome, probiotic & postbiotic terminology

Microbiome Supplement Formulation and ISAPP Definitional Discipline · ISAPP postbiotic · synbiotic · strain-level identity · WGS probiotic

In short

Term — microbiome, probiotic and postbiotic definitions: microbiome supplement discipline — ISAPP consensus definitions (probiotic 2014, prebiotic 2017, synbiotic 2020, postbiotic 2021), strain-level identity by whole-genome sequencing with culture collection deposit, antimicrobial resistance gene screening and stability indicator per product type (CFU for probiotic, bioactive marker for postbiotic, substrate retention for prebiotic).

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
Where this term comes up
Dietary Supplements
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.
Lab & QC — results against the limit, reviewed by a second person.
Sample plans, requests, lab queues and results in the same system as production. Reviewed results feed certificates of analysis and the release review; people decide.
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.
Labels — designed, approved, checked and printed in one place.
Many plants run a separate label tool beside their production records, so label versions drift and reprints go unrecorded. In V5 the label designer, approval, printing and the recipe's label details sit with the production record: the barcode scheme set on a recipe is checked when the operator packs, and the approved artwork revision is printed on the batch record. Printer connections are configured per workspace.
Related terms
Probiotic CFUICH Q1AClaims SubstantiationEU Novel Food Regulation (EC) 2015/2283
Software that covers Microbiome, probiotic & postbiotic terminology
V5 Ultimate LIMS
V5 includes laboratory information management alongside production and quality: sample plans, requests, lab queues and results…
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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