Decentralized Manufacturing and Compliance in Modern Pharmaceutical Manufacturing

The regulation focuses on requirements around designing a decentralized manufacturing platform using a hub-and-spoke model. In this model, a central manufacturing facility works with local point-of-care (POC) units that can either collect samples or use the central facility’s core product to develop cell or gene therapies in a bioreactor.

A Hub-and-Spoke Approach to Manufacturing

Historically, each of these facilities needed to be registered on the FDA listing. The new approach proposes that a centralized quality system could accommodate the individual spokes as Distributed Manufacturing Units (DMUs) within a centralized Distributed Manufacturing Establishment (DME).

Moving toward this model can provide significant advantages, including:

• Manufacturing closer to the patient
• Reducing transit times and associated risks
• Reducing the number of required registrations
• Potentially saving companies millions of dollars over the next five years

Supporting a Centralized Quality System

A Unified Pharmaceutical Quality System (UPQP) can help identify potential risks within a Contamination Control System (CCS).

As part of this approach, a centralized Facility Monitoring System (FMS) implemented using FacilityPro® and Pharmaceutical Net Pro components can be linked back to validation, supporting the requirements of the new regulation.

Learn More About Decentralized Manufacturing

Want to learn more about decentralized manufacturing and the changing regulatory landscape?

Watch the webinar: Decentralized Manufacturing

If you have any questions, please do not hesitate to contact us.