FDA releases guidance on pharmaceutical manufacturing

Jan. 6, 2016

The FDA proposes a pathway for pharmaceutical companies seeking to modernize their manufacturing technology to improve drug quality.

The U.S. Food and Drug Administration (FDA) has published draft guidance aimed at supporting the development of advanced technology in pharmaceutical manufacturing.

In a document titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base — Guidance for Industry,” the FDA proposes a pathway for pharmaceutical companies seeking to modernize their manufacturing technology to improve drug quality.

The agency notes that issues in pharmaceutical manufacturing have the potential to significantly impact patient care, as failures in quality may result in product recalls and harm to patients. What’s more, failures in product or facility quality are a major factor leading to disruptions in manufacturing.

Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that drug products will provide the expected clinical performance.

The agency gives the example of contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies, potentially decreasing the risk of contamination from the processing line. Encouraging the development of emerging manufacturing technology may lead to improved manufacturing, and therefore improved product quality and availability throughout a product’s lifecycle, the FDA says.

The document provides details of an optional program in which pharmaceutical companies can submit pre-submission questions and proposals about the use of specific emerging technology and work with the FDA’s Emerging Technology Team on the manufacturing design and required submission content related to the new technology.

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