FDA Audit Processes to Change Dramatically in May  
​[Posted on: Thursday, March 30, 2017]

The FDA’s Office of Regulatory Affairs (ORA), which is responsible for all audits conducted by FDA, is undergoing a major reorganization starting 17th May this year, which is expected to dramatically change how FDA audits. ORA will distribute its auditors into five specialized commodity-based groups, plus one group for clinical trial audits. This is radically different approach than the one that exists currently whereby one centralized ORA audits everybody. The change has been in the making for about 3 years when in February 2014 FDA’s then commissioner, Dr. Margaret Hamburg announced the decision to reorganize ORA audit programs into 6 groups, basically organizing auditors by Centers. One group each will audit manufacturing sites for products regulated by CDER/CVM, CBER, CDRH, CFSAN, and CTP, while all clinical trials will be audited by the BIMO group. Each group will be vertically integrated with the relevant Center by creating a cadre of compliance officers who have a similar level of technical expertise as the specialized investigators and who can work more closely with Center experts on complex scientific, manufacturing, or other regulatory challenges. Each FDA auditor will specialize in one kind of products to better align audits with the interest of the Centers that regulates that product. This change came about from requests by the various Centers at the FDA to address the rapid technical advancements and specialization within FDA-regulated industries. Over the years, FDA regulated products use increasing diverse and complex manufacturing processes based on advances in science. It had become increasing necessary to train auditors in sub-specialties in order to carry out effective audits of a given manufacturer. The reorganization will create 6 distinct groups within ORA each containing their own investigators, compliance officers, import reviewers, laboratory personnel and managers, which will coordinate closely with the respective Centers and Directorates. Clinical trials and GLP were the only areas where all Centers agreed that processes are similar enough to have a common audit group within ORA, namely BIMO. This major change in the FDA audit process involves new training programs created by the Centers (about 17 specialized training have already been announced), rewriting of the internal SOPs, updated import strategies, and laboratory optimizations based on the group that a testing lab belongs to. This change is purely reorganization and does not involve any layoffs and hiring new personnel. Also, the change affects the internal working of the FDA and does not change the overall policies regarding compliance. Rather this assures that the next auditor that shows up at a given site is well versed in the operations of that site. Since the auditors will be trained by subject matter experts at the Agency, audit findings should be better aligned with the views of the reviewers and help create a seamless connection between the auditors and reviewers, a much needed improvement in the process. This is also the first of its kind formal organization of auditing departments at a regulatory agency which may be an attractive model for other regulators. Once again FDA leads the way.