Annex 1 Alignment at INTERPHEX 2024: Addressing Contamination Control and Assessing Risk

Editor's Note: This interview was originally published on PharmTech.com.

Compliance with the European Union's Annex 1 updated guidance on the manufacture of sterile products is imperative for industry working within the EU or servicing EU-based clients. In an interview at INTERPHEX 2024, BioPharm International sat down with two experts in the field to discuss some of the major challenges being faced by industry in their continued effort to align with the sterile processing guidance.

"Across the industry, what we're seeing is a lot of people are at different states for Annex I in their facilities; many have done their gap analysis, they have a timeline to compliance, and are starting to work on projects, [while] others are just starting to understand where they are in the Annex 1 world and what that really means," said Christa Myers, senior fellow and vertical market leader, Aseptic & Sterile Products at CRB Group.

Myers noted that for many in the industry, implementing a contamination control strategy has proven complex, requiring manufacturers to take a very close look at project-related risk. That requires accessing and evaluating data, which may necessitate some companies having to retrofit or replace in order to obtain those data.

Another challenge is standardization. "When we have these industry workshops, I think that's more of what we're looking for is, 'How do we get a site to that point, instead of kind of leaving every individual site to do it on their own, and to figure it out on their own?' And that's how we end up with so many different looks to address the same issue," Nadiyra Walker Speight, senior director, Drug Product & Finished Goods at Fujifilm Diosynth Biotechnologies, pointed out. "That's one of the mindsets that I'm looking for is that we're not all attacking this from different angles, that we're able to interpret the regulation together and actually come up with solutions together," she continued. Myers agreed, calling for a more "harmonized approach" to implementation.