Memorandum of Understanding Between The Office of Regulatory Affairs and The Center for Drug Evaluation and Research on the Pharmaceutical Inspectorate

FDA oversees the quality of drug products using a two-pronged approach involving review of infonnation submitted in applications as well as inspection of manufacturing facilities for confonnance to requirements for current Good Manufacturing Practices (cGMP). These two programs have served the consumer well by helping to ensure the quality of drug products available in the U.S. Now, as we approach the 25th anniversary of the last major revision to the drug cGMP regulations, it is time to step back and evaluate the currency of these programs and implement new ones, as appropriate, so that our resources are used most effectively and efficiently to address the most significant health risks. To this end, the Office of Regulatory Affairs and the Center for Drug Evaluation and Research have agreed to develop a Pharmaceutical Inspectorate (PI) of highly trained investigators whose primary responsibility will be conducting drug quality inspections.