4. What is meant by the terms Qualified Person (QP) release and Qualified Person certification?

The terms QP release and QP certification, are often (incorrectly) used interchangeably. However the responsibilities for release and certification are defined in clinical trials legislation. EUGMP Annex 13, Paragraph 44 requires IMPs remain under the control of the sponsor until after completion of a two-step procedure: Certification by the QP; and release following fulfillment of the requirements of Article 9 (commencement of a clinical trial) of 2001/20/EC.

The QP has a legal responsibility as laid out in Article 13 of 2001/20/EC to ensure that the IMP has been manufactured in accordance with EU GMP and meets the conditions of the clinical trial authorisation and the product specification file (PSF). In certifying a batch against the PSF, investigational medicinal product dossier or the clinical trial authorisation (CTA) the QP is providing certification, which has been known previously as the technical green light.

Release of IMPs for use in a clinical trial should not occur until after the QP has certified the batch(s). Under Article 9 of 2001/20/EC, the sponsor may not start a clinical trial until the clinical trial authorisation has been granted for the trial and all conditions of the authorisation have been met; and an Ethics Committee positive opinion has been granted and each trial site has been approved. The process for ensuring that the appropriate approvals are in place has been known previously as the regulatory green light.

In practice, although the QP certification and regulatory approval processes may be run in parallel, the sponsor is responsible for ensuring both steps are completed prior to the release of IMPs for use in a clinical trial. The QP certification must be provided by a QP named on the MIAIMP licence specified in the clinical trials authorisation as responsible for the manufacturing and importation of the IMP. The regulatory green light release may be delegated by the sponsor to the QP, regulatory affairs or trial manager. However the sponsor retains legal responsibility.