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.
Procurement and processing of TC, conducted by TEs under aseptic conditions, are among the most critical and complex processes that entail some level of contamination risk. Failure in any step of these processes may lead to microbiological contamination and loss of TC, and may even pose a potential health risk for the recipient if the contamination is not detected before the TC are used.
The working group responsible for the elaboration of the most recent (5th) edition of the Guide to the quality and safety of tissues and cells for human application has developed a new EDQM online tool for a systematic risk assessment of the microbiological contamination.
The MiRCA tool is aimed at:
- helping users identify potential risks in novel, existing or modified aseptic processes;
- alerting users to the degree of risk of introducing microbiological contamination during the procurement or processing of TC;
- supporting decisions and measures to mitigate risks during aseptic processes.
The tool generates a summary report detailing the risks identified and the risk scores, and prompts users to record the rationale for decisions taken and the evidence used to support them.
This webinar covers the presentation of MiRCA. The developers walk the participants through the tool and explain how it works using real-life examples.
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Duration: 2 hours, 26 minutes.
Target audience
- Professionals working in organisations that handle TC for human application, in roles such as Quality Manager or Responsible Person
- Organisations that procure TC
- Tissue establishments processing and storing TC
- Organisations responsible for human application of TC
- Fertility clinics
- Bone marrow and cord blood collection centres
- Inspectors auditing the establishments and organisations responsible for human application of TC
- Health Authorities responsible for TC
00:00:00: Introduction by the EDQM, Laurent Mallet
00:12:44: Introduction to the 5th Edition of the T&C Guide, Akila Chandrasekar & Jacinto Sánchez Ibáñez
00:27:54: Introduction to the MiRCA tool - setting the scene, Johan Guns
00:47:24: Let’s get to the point: how does MiRCA work? Johan Guns
01:05:06: What is the goal of a mock assessment? Richard Lomas
01:20:19: Mock processing assessment, Jaime Tabera
01:33:10: Relevance of MiRCA to tissue establishments and health authorities, Akila Chandrasekar
01:37:33: Questions & Answer Session
02:22:44: Take home messages, Jacinto Sánchez Ibáñez
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