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FDA and Pharma to Collaborate on Manufacturing Tech Program

The latest draft guidance invites drug makers to work with the agency’s new Emerging Technology Team to implement modern technologies that will improve processes and increase Quality by Design.

The latest draft guidance invites drug makers to work with the agency’s new Emerging Technology Team to implement modern technologies that will improve processes and increase Quality by Design.
The latest draft guidance invites drug makers to work with the agency’s new Emerging Technology Team to implement modern technologies that will improve processes and increase Quality by Design.

In an effort to reduce drug shortages while increasing drug quality, the U.S. Food and Drug Administration recently released a draft guidance on the use of cutting-edge technology in manufacturing, and is inviting pharmaceutical companies to participate in an implementation program.

The document entitled the “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base,” is intended to overcome the current obstacles associated with the deployment of new technologies throughout the manufacturing process.

Specifically, the FDA outlined a plan for modernizing drug manufacturing back in 2002 when it launched the “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.” The initiative encouraged early adoption of modern quality assessment systems.

In 2004, a follow on to that called “PAT—A Framework for Innovative Development, Manufacturing, and Quality Assurance,” recommended that quality not be tested after production, but built-in by design.

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