FDA Warning Letter highlights risks of using AI in drug manufacturing

In the United States, facilities that manufacture drugs must implement quality systems that comply with current good manufacturing practice (cGMP) regulations in 21 CFR Parts 210 and 211. While cGMP requirements are not new, the manner in which companies have implemented the regulations has evolved since the 1970s, from paper records to computerized systems, and more recently, to tools incorporating artificial intelligence (AI). The failure to do this correctly can lead to adverse inspectional... By: DLA Piper