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Compliance

Annex 13

EU GMP Annex 13 — Investigational Medicinal Products · imp gmp · investigational medicinal products annex

TL;DR

EU GMP rules for IMPs used in clinical trials — sponsor responsibilities, QP certification, blinding, and reconciliation.

Annex 13 governs the manufacture, labelling, QP certification, shipping, blinding, and reconciliation of Investigational Medicinal Products (IMPs) used in clinical trials. It defines the sponsor's GMP obligations, requirements for the product specification file, randomisation/code-break controls, and accountability of returned and unused IMP.

V5 treats IMPs as first-class records: blinded labels, randomisation lists, kit assembly, site shipments, and per-subject reconciliation all flow through eBMR/eDHR with Part 11 controls.

Regulatory anchors
  • EU GMP Annex 13
Industries that live with this
Pharmaceutical
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
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.
Related terms
QP releaseAnnex 1EU Annex 1121 CFR Part 11
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