MIRCA: An EDQM tool to enhance safe use of substances of human origin (Catapult’s regulatory round-up – April)

The EDQM recently released the Microbiological Risk of Contamination Assessment tool (MiRCA), which aims to help users identify and classify potential risks for introducing microbiological contamination during the procurement or processing of tissues and cells, and supports decision making to mitigate such risks. MiRCA complements the Guide to the quality and safety of tissues and cells for human application. 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. MiRCA can be accessed here and a supporting how-to webinar is available here.

Published on the 2nd of May 2023 in Catapult’s April regulatory round-up.