FDA’s Quality Office Promotes Modernization

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CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

In a blog posted on FDA.gov, Michael Kopcha, PhD, director of the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER), states that FDA plans to help the pharmaceutical industry modernize manufacturing as a part of ensuring the quality of medicines.  In the blog, Kopcha mentions FDA guidance on new technologies and the establishment of a team dedicated to new technologies as two of the ways the agency is working to promote technological advances in the industry.

“When manufacturing problems arise in drug manufacturing facilities, drug shortages may follow,” states Kopcha in the blog. “In fact, 65% of all drug shortages are caused by manufacturing and quality issues. This underscores the need for a safe and reliable drug supply chain.”

Citing the efforts other industries have made to embrace advanced technologies in order to improve quality, Kopcha says the pharma industry can create a more robust and efficient manufacturing process by adopting new technologies. “This will minimize product failures and provide greater assurance that the product will consistently deliver the expected clinical performance,” says Kopcha.

The director points to FDA’s approval of the first 3D printed pill as an example. “By adopting this novel technology, the drug maker is able to produce pills that can disintegrate more rapidly in a patient’s mouth, greatly aiding those who have trouble swallowing. This approval is a strong example to FDA’s efforts to put emerging technology to work for the health of Americans,” says Kopcha.

In a continued effort to advance technology, FDA established the Emerging Technology Team (ETT), which works with industry to resolve scientific issues for new technologies. The ETT creates a dialogue between industry and FDA from early technology development to submission of a drug application. According to Kopcha, “such early engagement enables FDA to proactively identify and address potential roadblocks and helps eliminate potential delay in the adoption of promising new technologies.”


In December 2015, FDA issued draft guidance explaining ETT and providing recommendations for drug manufacturers for obtaining FDA feedback on the development of novel manufacturing technologies.  

“Expanding this program will not only help to prevent drug shortages, it will help reinvigorate our country’s pharmaceutical manufacturing sector while fulfilling a critical part of FDA’s mission: ensuring that safe and effective drugs are consistently available to the American public,” says Kopcha.

Source: FDA