The European Directorate for the Quality of Medicines & HealthCare (EDQM) recently unveiled the Microbiological Risk of Contamination Assessment tool (dubbed “MiRCA”), which aims to improve the safety and efficacy of substances of human origin (SoHO) used for therapeutic purposes.
The MiRCA tool, which complements the Guide to the quality and safety of tissues and cells for human application, is designed to help users identify potential risks in aseptic processes, alert them to the degree of risk of introducing microbiological contamination during the procurement or processing of tissues and cells, and support decision making to mitigate such risks. The tool generates a summary report detailing any risks identified, grading risk severity, and prompts users to record the rationale for their decisions and any evidence used to support them.
To promote the use of the MiRCA tool, the EDQM held a successful webinar last January. Over 500 participants, connecting from 62 countries, from tissue establishments, fertility clinics and health authorities took part. Experts from the Working Group of the 5th edition of the Tissues and Cells Guide walked participants through the tool, demonstrating how it can be of invaluable assistance in the field of tissues and cells.
The agenda, recordings and presentations are available online in the EDQM catalogue of events and training resources.
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