To help ensure quality and safety in the field of substances of human origin (SoHO), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been entrusted with managing the EuroGTP II tool for good tissue and cell practices. Starting on 15 November 2023, this interactive assessment tool will be hosted on the EDQM SoHO platform, along with the Microbiological Risk of Contamination Assessment (MiRCA) tool.
Bookmark the new web address of the EuroGTP II tool
Support tools for SoHO technical guides
Identifying, quantifying and assessing the level of risk associated with novel SoHO preparations using a standard process is of crucial importance. 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 and therefore pose a risk for donors or recipients. The EuroGTP II tool can help assess such 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.
New users can access the EuroGTP II and Microbiological Risk of Contamination Assessment (MiRCA) interactive risk assessment tools free of charge after creating an account on the EDQM’s SoHO tools platform. The same user account is valid for both tools, and makes it possible to store specific assessment data for up to five years.
If you are already a MiRCA user, log on to your existing account to discover the new version of the EuroGTP II tool, along with the updated user guide published on this occasion.
If your team or establishment would like to benefit from the use of these specialised SoHO support tools, create your free account on the EDQM SoHO platform and make the most of this opportunity.
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