---
title: "Qualified Person — Definition | QbD Group"
description: "The named individual legally responsible under EU law for certifying that each batch of a medicinal product was manufactured and tested in line with GMP..."
url: https://qbdgroup.com/en/knowledge-center/glossary/qualified-person
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Qualified Person — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/qualified-person"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# Qualified Person

Quality & GMP

## Definition

The named individual legally responsible under EU law for certifying that each batch of a medicinal product was manufactured and tested in line with GMP and the marketing authorisation before it is released to the market.

QP batch release

## Related terms

[GMPThe set of rules ensuring medicinal products are consistently produced and controlled to the quality standards required by their intended use and marketing authorisation. In Europe it is set out in EudraLex Volume 4; in the US in 21 CFR Parts 210 and 211.](https://qbdgroup.com/en/knowledge-center/glossary/gmp)[GDPThe quality standard for the storage, transport, and distribution of medicinal products. It covers wholesale licensing, qualified personnel, temperature control and mapping, supplier and customer qualification, and the handling of returns and falsified medicines.](https://qbdgroup.com/en/knowledge-center/glossary/gdp)[GLPThe quality system governing how non-clinical safety studies are planned, performed, recorded, reported, and archived, so that regulators can rely on the data submitted in a marketing application.](https://qbdgroup.com/en/knowledge-center/glossary/glp)[ISO 13485The international standard for quality management systems specific to medical devices. Certification is the practical route to demonstrating the QMS requirements of MDR Article 10 and IVDR Article 10, and is expected by most notified bodies and customers.](https://qbdgroup.com/en/knowledge-center/glossary/iso-13485)[QMSThe documented set of processes, responsibilities, and records through which an organisation plans, controls, and improves product quality and regulatory compliance, from design and supplier control through production, release, complaints, and CAPA.](https://qbdgroup.com/en/knowledge-center/glossary/qms)[CAPAThe quality process for investigating a problem, correcting it, addressing its root cause so it does not recur, and preventing similar issues elsewhere. Effectiveness checks close the loop, and CAPA records are a standard focus of inspections and audits.](https://qbdgroup.com/en/knowledge-center/glossary/capa)

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