Quality

QP release

Qualified Person release · qualified person release

EU GMP — only a named Qualified Person can certify a batch for market release.

Under EU GMP (Directive 2001/83/EC, Annex 16), a finished medicinal product can only be placed on the EU market once certified by a Qualified Person (QP). The QP reviews the full batch dossier — manufacturing record, deviations, change controls, OOS, stability — and signs the certification. V5 packages every batch's full dossier into one signed bundle so the QP review takes minutes, not days.

Regulatory anchors

EU GMP Annex 16

Industries that live with this

Pharmaceutical

How V5 handles it

QC release — your reviewer sees only what failed.

By the time a batch reaches QC, every signed step has already rolled up. Your reviewer reviews-by-exception, signs, and releases — with the deviations and CAPAs already linked.

Related terms

BMR

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