EDQM launches updated version of the EuroGTP II tool to ensure good tissue and cell practices for human application (From Catapult’s regulatory round-up – November 2023)

To help ensure quality and safety in the field of substances of human origin (SoHO), the EDQM has been assigned to manage the EuroGTP II tool for good tissue and cell practices. This interactive assessment tool is now available on the EDQM SoHO platform, along with the Microbiological Risk of Contamination Assessment (MiRCA) tool. Identifying, quantifying and assessing the level of risk associated with novel SoHO preparations using a standard process is highly important as any modification in processes associated with the donation, procurement, testing, processing, storage and distribution of such preparations may impact the quality and/or safety of SoHO-related therapies and products. The EuroGTP II tool can help assess these risks through three interactive steps:

• determine if a SoHO preparation or process has any novelty;
• assess the risks associated with the SoHO preparation or process;
• determine the extent of any studies and/or follow-up required to guarantee the safety and efficacy of the SoHO preparation or process.

Please find further information here.

Published on the 5th of december 2023. Read Catapult’s entire regulatory round-up here.

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