Good Distribution Practice is on the Verixa roadmap
Cold-chain integrity and distribution quality sit at the GMP/GDP boundary. GDP is on the Verixa roadmap, not in Phase 1.
GDP is a roadmap commitment, not a current module. Verixa Phase 1 focuses on GMP Core today; GDP is planned for 2028+ and built on customer pull, not founder push.
Manufacturers with export footprints, distributors and cold-chain logistics providers — operations where a temperature excursion at 2 a.m. in a third-party warehouse must become a governed quality event by morning, with a disposition decision someone qualified is accountable for.
The regulatory context we are designing for
Distribution and cold-chain quality extend the GMP evidence story to logistics — temperature excursions, lane qualification, and warehouse quality. Verixa Phase 1 focuses on GMP Core; GDP is planned for Phase 3 (2028+), built on customer pull.
EU GDP 2013/C 343/01
EU Good Distribution Practice guidelines for medicinal products.
WHO TRS 957 Annex 5
WHO good distribution practices for pharmaceutical products.
MHRA GDP
UK distribution quality and Responsible Person expectations.
USP <1079>
Good storage and distribution practices for drug products.
What this demands of a quality system
Excursions handled as quality events — temperature, handling, security — captured with evidence, assessed for product impact, dispositioned by qualified people.
Supplier, carrier and lane qualification — transport routes and partners qualified and requalified on evidence, not tenure.
Returns and suspect-product decisions — falsified-product suspicion, damaged goods, recalls — every decision traceable end to end.
Responsibility across partners — quality agreements that mean something because the records they govern are shared, linked and auditable.
The Phase 1 foundations GDP will build on
The Phase 1 GMP Core architecture — schema-level audit trail, MIRA advisory + HITL, and Evidence & Validation — is designed to extend into GDP. None of it claims GDP coverage today.
Planned · not yet built
Good Distribution Practice
Schema-level audit trail
The schema-level audit trail extends to excursion and lane-qualification records, logging the evidence and the human decision.
MIRA advisory + HITL
MIRA’s advisory + human-in-the-loop pattern fits excursion triage — surfacing the gap, never releasing the shipment.
Evidence & Validation
The Evidence & Validation structure generalises from a GMP workflow to a distribution-quality workflow.
Per-tenant isolation & e-sign
Per-tenant data isolation and e-signature audit objects (controls under verification) apply to distribution records unchanged.
In Phase 1
GMP Core foundation
Every foundation above is already live and load-bearing in GMP Core. GDP reuses this architecture — it adds no GDP coverage today.
On the GDP roadmap — planned, not yet built
These are design intentions for the GDP roadmap, phrased as intent — not capability claims. Nothing here is available today; each is built only when design-partner pull justifies the engineering.
Excursion workflows with product-impact assessment on the governed spine.
Carrier and lane qualification records.
Returns and suspect-product decision workflows with end-to-end traceability.
Partner-facing evidence on the sealed-pack model.
Express interest in the GDP roadmap
GDP is targeted for Phase 3 (2028+), pending customer pull. Join the waitlist to help shape the GDP roadmap and to be considered for the early design-partner cohort.
Expressing interest is lead capture for a future phase — it is not an order, a demo request, or a claim that GDP is available.