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Operations professionals address the impact of new regulations on manufacturing facility design. 

Pharmaceutical Manufacturing Facility Design

When it comes to manufacturing facility requirements, regulations and expectations never get less stringent, says Nadiyra Walker Speight, senior director, Drug Product & Finished Goods, at Fujifilm Diosynth Biotechnologies. With that in mind, Speight, who recently sat down for an interview with 

, said that industry should always be aiming to exceed compliance expectations knowing that it's a moving target. 

Speight, who was joined by Christa Myers, senior fellow and vertical market leader, Aseptic and Sterile Products at CRB Group, agreed that new regulations, especially those spelled out within the European Union's Annex 1 guidance, can pose a significant challenge for pharmaceutical manufacturers. 

"Cost is ever-present. These facilities get bigger and bigger and bigger. We're starting to understand capacities for patients and companies so we can right-size facilities and get down to right costs for these facilities," Myers commented, agreeing with Speight that having an operations professional closely involved in facility design can help navigate difficult decisions that pin construction cost and time against efficiency in facility operations. 

In the interview, Myers and Speight further address the effects that the Annex 1 guidance are having on facility design and the importance of ongoing, quality-focused training for operations-level professionals to ensure the delivery of an optimal product. 

Click here for more coverage of INTERPHEX 2024. 

Videos

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance. 

How New Regulations Are Impacting Pharmaceutical Manufacturing Facility Design

Experts in sterile processing address challenges related to implementing guidance from the EU's Annex 1.

Annex 1 Alignment: Addressing Contamination Control and Risk Assessment

 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 

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 

, 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. 

Click here for more coverage from INTERPHEX 2024

At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1. 

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