EU Guidelines for Good Manufacturing Practice, Annex 16¶
European Commission. (2015). EU Guidelines for Good Manufacturing Practice, Annex 16: Certification by a Qualified Person and Batch Release.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Mechanisms¶
- Release Hold and Signoff
- Release requires that identity, potency, sterility, and the batch record all pass, and that a designated authority reviews the dossier and signs.
This sourceEU GMP requires Qualified Person certification, grounded in review of manufacturing and testing evidence, before a medicinal-product batch may be released.
- Release requires that identity, potency, sterility, and the batch record all pass, and that a designated authority reviews the dossier and signs.
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Registry ID ref:1015ffe7f326 · see in the full table