Conor Murray, Convenor of ISO/TC209 WG2 on Microbiological Contamination Control and Chair of the Irish Cleanroom Society, will co-chair a session on Annex 1 and speak at the Next Generation Pharmaceutical Cleanroom Conference in London on 5th October.

Murray will present a paper entitled Navigating the Latest GMP Guidelines and Regulatory Compliance, where his subjects will include alignment between regulatory guidelines and ISO/CEN standards, the challenges of integrating holistic QRM with respect to the new Annex 1, and aRMM (Additional Risk Minimisation Measures) enabling next generation pharmaceutical cleanrooms to support Pharma 4.0, PAT and RTRT.

In addition to his industry society roles within the contamination control sector, Murray also serves as the BioTrak® Real-Time Viable Particle Counter product specialist in Ireland for Validair Monitoring Ireland Ltd.

“I believe Annex 1 will drive the increasing adoption of aRMM technologies, not only in CGT/ATMP, with short shelf-life products, but in wider Pharma/Biopharma applications due to uncertainties and limitations of delayed results, data integrity and the level of manual intervention in traditional sampling-based EM methods. Annex 1 will challenge us to better understand our manufacturing process and the impact of contamination sources,” says Murray, adding: “The BioTrak, with real-time viable airborne particle counting and a validated Non Inferior alternative method, is a game changer for root cause analysis and immediate intervention when a contamination event occurs.”

The Annex 1 update introduces a formal requirement to apply QRM and develop a documented contamination control strategy, which is expected to encourage the scientific adoption of new

Delegates attending the conference will be able to ask questions of Murray and seek advice on how best to implement Annex 1 and address all aspects of continuous environmental monitoring (EM).