Conor will present a paper entitled 'Annex 1 – a “Call to Action” to adopt new technology and mitigate risks in support of Pharma 4.0.' The presentation will cover new Annex 1 in the context of its guidance and application to GMP cleanrooms. As Convener of ISO/TC 209 Working Group 2 on Microbiological Contamination control, Conor will share his interpretation and guidance, particularly in relation to QRM and creating a Contamination Control System.

"The new Annex 1 is a 'Call to Action' to support Pharma 4.0 and respond to the demands and challenges of new medicines and medical devices, including ATMPS/CGT and short shelf life products."

Conor points out that data integrity around traditional sampling-based methods must be improved and that new technologies such as biofluorescent particle counters should be considered in continuous EM to enable continuous manufacturing. He says that standing still is no longer good enough and that the expectation is a better understanding of processes and hazards in order to assure product quality and ultimately patient safety and well-being. The ISO 14644 family of standards, referred to in the new Annex 1, supports good science. The Life Science industry is ready to respond to the challenges.

The venue for this year’s Cleanroom Technology Conference is the impressive Marina Bay Sands Expo and Convention Centre.

Find more details of the conference here.