Coming soon: Microbiological Risk of Contamination Assessment tool for tissues and cells. All you need to know about the MiRCA tool.
The procurement, processing, storage and distribution of human tissues and cells (TC) intended for human application must comply with the highest standards of quality and safety aligned with the current regulatory framework, and the latest evidence based scientific requirements, in order to guarantee their safe and effective use.
This webinar covers the presentation of a new EDQM on-line tool: Microbiological Risk of Contamination Assessment (MiRCA) created by the working group for the elaboration of the most recent 5th edition of the Guide to the quality and safety for tissues and cells for clinical application.
The goal of the MiRCA tool is to prevent TC loss due to microbial contamination during aseptic (procurement and processing) processes, and to reduce the risk of transmission of infection to recipients. The MiRCA tool provides a structured and systematic methodology for enabling TEs to identify, quantify and mitigate contamination risk of well established, or novel aseptic process.
The MiRCA tool provides users with a simple, guided steps for assessment of TC’s microbiological safety addressing as well the CAPA process or change-control process. During the risk assessment of the specific aseptic process this tool can be complemented with, the EU funded, Euro GTP-II Interactive Assessment Tool for calculation of the risk index (probability of microbiological contamination and the impact).