A Qualified Person (QP) is an individual with defined qualifications and experience who is named on a manufacturing or import authorisation in the EU or UK. Under Directive 2001/83/EC, each batch of a medicinal product must be certified by a QP before release, confirming that it was manufactured and checked in accordance with GMP and the requirements of its marketing authorisation. In the UK, the Human Medicines Regulations 2012 carry the same requirement.
EU GMP Annex 16 describes how QP certification works: what the QP must confirm, how they can rely on other QPs and on the pharmaceutical quality system across the supply chain, and how certification is recorded in a register. The QP does not have to perform every check personally, but must be satisfied — on the basis of evidence — that every required step has been completed.
Why it matters in GMP
The QP carries personal legal responsibility for each certification. That makes the quality and accessibility of the evidence crucial: the QP needs a complete, trustworthy view of the batch record, test results, deviations and supply chain before signing. Outside the EU and UK — for example in the United States or India — there is no QP role, and release is the responsibility of the quality unit.
- Give the QP one complete evidence package per batch.
- Make open deviations, OOS results and CAPAs visible before certification.
- Keep the release decision attributable, signed and auditable.
How Swat iQua Suite helps
Swat iQua Suite does not replace the QP’s certification. It gives the QP or QA releaser a complete release dossier per batch, with critical evidence checked against live system data, automatic blockers for open deviations, OOS, CAPAs and sterile failures, and an e-signed QA release decision that the batch executor cannot make.