HQ Cortex
All compliance regimes

NSF/ANSI 455-2 — GMP for Dietary Supplements

Retailer-driven third-party GMP standard built on top of 21 CFR Part 111.

Supported
1(20%)
In progress
2(40%)
Not yet planned
2(40%)
Tracked5

Why this matters: NSF/ANSI 455-2 is the third-party certification many large retailers (Costco, Walmart, Amazon) effectively require for dietary supplement vendors. Because it is layered on top of 21 CFR Part 111, every requirement in our cGMP page also applies here, plus a few audit-packet specifics.

This is a core regime in scope for the default product.

Status legend

  • SupportedWe can do this today.
  • In progressPartially in place or actively in development.
  • Not yet plannedNot yet started or not in scope.

Audit-Packet Essentials

  • Approved supplier file with COA enforcement

    Supported

    Approved supplier list with qualification status; COA reviewed before lot release; COAs missing required tests flagged.

    In HQ Cortex: Supplier COAs, certifications, and audit records together provide the evidentiary trail.

    NSF/ANSI 455-2 §6

  • Identity testing per incoming component lot

    In progress

    Workflow that confirms at least one identity test per dietary-ingredient lot before use.

    In HQ Cortex: QC test capture exists; mandatory gate at quarantine release is partial.

    NSF/ANSI 455-2 §7

  • Annual product review export

    In progress

    Per-product report aggregating batch yields, OOS rate, complaints, deviations, and stability data.

    In HQ Cortex: Most underlying data is in the system; a packaged annual-review export is being built.

    NSF/ANSI 455-2 §10

  • Adverse event reporting hooks

    Not yet planned

    Generate MedWatch 3500A-ready data export for serious adverse events.

    In HQ Cortex: No structured adverse-event capture or 3500A export today.

    DSHEA §761; NSF/ANSI 455-2 §11

  • One-click recall list per lot

    Not yet planned

    Given a component lot, list every downstream batch and customer shipment.

    In HQ Cortex: The data graph supports this query; a turnkey recall-list export is on the roadmap.

    NSF/ANSI 455-2 §11; 21 CFR 7.40

References

Last reviewed: May 2026.