FDA’s Audit Manual Updated: Surprisingly No Surprising Changes

This week FDA published the updated inspections manual which does not contain any obvious major changes to the previous version. Earlier this year FDA’s Office of Regulatory Affairs was reorganized to improve the quality of inspections. However, the inspections manual does not reflect those changes. The “Investigations Operations Manual”, also known as the Audit Manual, describes all the processes FDA inspectors use during audit of a regulated organization and used to train FDA’s auditors. The manual is still covers FDA-wide operations for all kinds of regulated products. It is not obvious if any specific training has been included to align the auditors with the area of inspection they are responsible for. That said, the training of the FDA inspectors is multi-dimensional and the manual is one of the several documents inspectors are trained on. The Audit Manual is an excellent resource to auditors and companies alike in the basic rules of an FDA audit. It describes the process, the scope and the laws governing an FDA audit. It contains several useful details on how FDA inspectors are expected to audit a given establishment and what resources they have at their disposal. It also highlights the subjectivity of the audit process where the FDA auditors makes judgments about what he/she observes such as is the site is refusing to allow the audit or just needs more clarification on the questions asked. It is a great resource for anyone getting audited by FDA or just wanting to know more about the process. However, it would have been nice if it also highlighted the key changes that are being implemented in the auditing process to align this manual with the reorganization of the Office of Regulatory Affairs. Given the importance of this manual as the central document used by all FDA auditors, the manual is an important public document to highlight FDA’s internal processes. As such this update missed an important opportunity to educate the industry and the public about what new to expect. Or maybe this was FDA’s way of telling the industry that despite the reorganization, the core auditing processes will not change.