How New Regulations Are Impacting Pharmaceutical Manufacturing Facility Design

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


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 Pharmaceutical Technology at INTERPHEX 2024, 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.

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