Gordon Farquharson, MD of Critical Systems and convenor of ISO TC2019 WG1, will return as speaker of the Cleanroom Technology Conference (16-17 May 2018, Birmingham). He will address the potential impact of the proposals for cleanroom and cleanair device specification, classification, and monitoring following the revision of Annex 1 of the EU GMP Guide for manufacturing of sterile medicinal products. The draft was released in December last year.
An industry first, this revision has been compiled by regulators from the European Medicines Agency (EMA), World Health Organization (WHO), and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Players in the industry have been waiting for the update for two years. Experts in the field have already noted the 50-page draft brings significant changes to the marketplace.
“The different constitution of regulators that have been writing the document is likely the reason why it is so different from the current version,” Farquharson commented. He pointed out the draft revision is a Western GMP version with a South East Asian environment given the input by PIC/S members from emerging markets such as Singapore.
The final Annex 1 will be legally binding, and everyone in the industry has until 20 March 2018 to submit feedback on the proposed changes. Farquharson believes the joint EMA- WHO-PIC/S committee could take a year to release the outcome of the consultation. As it stands, the proposed regulation and guidance brings significant change for cleanroom operators, sterile medicine manufacturers, and the entire supply chain. Farquharson explained: “The proposed GMP would require investment in technology and operational changes. There will be changes to environmental monitoring, changes to cleanroom classification, potentially changes to water systems, and there are changes to some manufacturing processes as well. So yes, the new Annex 1 will have a big impact.”
Farquharson's session at the Cleanroom Technology Conference 2018 will shed light on the potential impact of the proposals. Scheduled on day one, his address will focus on the proposed new requirements for isolators and restricted access barrier systems. “If you read the GMP it is quite clear that having people in cleanrooms is bad news. Companies should consider the technologies that separate people from processes. This could be machine automation and could be robotics,” Farquharson said.
Could Annex 1 consolidate the use of automation in cleanrooms? And how can companies prepare for the challenges ahead? Delegates from around the world will gather at the National Conference Centre, Birmingham, for the Cleanroom Technology Conference 2018 to debate these questions and more. Visit the conference's website for more information about the event.
