6-8 November 2023
Investigational medicinal products (IMPs) may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP". The Draft of the guideline was published in 2018. Following the entry into application of the CTR at the beginning of last year the final version of the guideline has been released. The date of coming into effect was 1 January 2023.
According to the Template for IMP batch release, the first step is the certification of each batch by the Qualified Person (QP) of the manufacturer or importer in line with the Clinical Trials Regulation (EU) No 536/2014 (CTR) to ensure that the provisions of the CTR and those set out in Article 12 (Responsibilities of the QP) of the Commission Delegated Regulation (EU) No 1569/2017 have been complied with and documented. The second step is the regulatory release by the sponsor (i.e., the verification of completion of batch certification by the QP and the necessary authorisations in place for the clinical trial, before supply of IMP to the clinical trial site) for use in a clinical trial. Both steps should be recorded and retained in the clinical trial master file (TMF). IMPs should remain under the control of the sponsor until the release process is complete.
It should be ensured that the shipping of the IMPs minimizes any risk of exposure to conditions that could impact quality and integrity of the product. This includes security of the product (e.g. against adulteration, tampering or theft), ensuring that the applicable GDP principles are taken into consideration, e.g. regarding documentation, transportation (including selection of container and packaging, qualification and/or validation activities, monitoring of transport conditions) and outsourced activities.
More information is available in the “Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice” published under Chapter III – Quality in EudraLex Volume 10.