Wednesday 3 February 2016

Advancement of Emerging Technology Applications

U.S. FDA has published new guidance of interest. The guidance is titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry.”

The guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology to FDA.

The program is open to companies that intend the technology to be included as part of an investigational new drug application (IND) or original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance.

According to FDA:

“Issues in pharmaceutical manufacturing have the potential to significantly impact patient care in that failures in quality may result in product recalls and harm to patients. Additionally, 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 the drug products manufactured in any given period of time will provide the expected clinical performance. For example, contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies have the potential to decrease 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”

For details, see FDA


Posted by Dr. Tim Sandle

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