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EU GMP · Annex 16

Certification by a Qualified Person and batch release.

Instrument: GMP annex, legally binding in the EUApplies to: Pharma manufacturing and importation (EU).

What the signed record shows

That the named Qualified Person personally made the certification decision, and what was before them when they made it.

The proof is a signed, tamper-evident record. Anyone can check it, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: EudraLex Volume 4, Annex 16

In the same family

FDA · 21 CFR 211.22Quality-unit authority to approve or rejectEU GMP · Annex 11Computerised-systems integrityEU GMP · Annex 22 (draft)Artificial intelligence in GMPFDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management

What to do about it

Keep the evidence this asks for, as the work happens.

A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer™. It runs inside your own environment and nothing has to leave it.

Life sciences: how the control worksOr verify a real record →

Part of the Regulayer™ proof catalogue: 151 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the annex requires, in outline

EudraLex Volume 4, Annex 16, Certification by a Qualified Person and Batch Release, effective 15 April 2016. The statutory model of a named, personally accountable human whose decision precedes a consequential action:

Personal certification
The Qualified Person certifies each batch personally before it is released for sale or supply. The responsibility attaches to a named individual, not to a function or a system.
A reasoned assessment, documented
Where deviations arise, the Qualified Person documents a reasoned assessment before certifying. The reasoning is part of the record, not merely the outcome.
Reliance on others, without transfer of responsibility
The Qualified Person may rely on the quality system and on the work of others, and remains personally responsible for the certification.
Why this one matters here
Batch certification is the clearest instance in the regulations of a decision that cannot be delegated to a system. Any AI that compresses the review preceding it raises the question of whether the signature remained a decision.

Nothing here is a claim about liability. The annex vests certification in a named person, and the point for a record is narrow: it should be possible to show afterwards what that person had before them and when they decided.

Built against the primary text published by the European Commission. Verified 17 August 2026.

This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.