V5 Ultimate
Compliance

Annex 16

EU GMP Annex 16 — Certification by a Qualified Person and Batch Release · qp certification annex

TL;DR

EU GMP chapter defining the Qualified Person's responsibilities and the batch certification process for release to the EU market.

Annex 16 codifies what a Qualified Person (QP) must personally ensure before certifying a batch for EU release: GMP compliance across the full supply chain, marketing authorisation conformance, sampling/testing adequacy, and handling of unexpected deviations. It also defines QP-to-QP confirmations between sites and the handling of imported products.

V5 surfaces every record a QP needs to certify — executed BMR, OOS log, change controls, deviations, supplier status, stability data — in one release dossier with audit-trail-backed e-signature.

Regulatory anchors
  • EU GMP Annex 16
Industries that live with this
PharmaceuticalRadiopharma
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.
Related terms
QP releaseConditional releaseAnnex 1DeviationChange control
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