New Guidances, Investigations to Shape Drug Manufacturing, Regulation in 2014

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices. There will be more advice on establishing a quality system approach to current good manufacturing practice (GMPs) and on quality agreements with contract manufacturers, according to the 2014 guidance agenda for the Center for Drug Evaluation and Research. Other documents will address use of cloud computing systems in manufacturing, interim GMPs for drug compounding outsourcing facilities, submission of field alert reports and biological product deviation reports, and electronic filing of information on manufacturing establishments.

Specifically related to chemistry, manufacturing and controls (CMC), FDA plans to provide advice on analytic procedures and methods validation, appropriate packaging for

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