FDA inspection or audit for Good Clinical Practices (GCP) is an important step for the FDA review of market approval applications. Although GCP audits have been conducted for more than 50 years, there has been little formal guidance from the FDA about the processes involved, leading to several anecdotes and perspectives. A new FDA guidance document, released last week, aims to educate the clinical site personnel about the basic processes for GCP audits.
FDA audits are an intimidating process where the FDA’s inspectors access, inspect, and copy records at the audited site, and interview the site personnel. Generally, an FDA audit involves the FDA inspectors physically entering the sites for the audit, in recent years, the FDA has frequently used remote auditing practices where the entire audit is conducted remotely, called the Remote Regulatory Assessments (RRAs). The RRAs involve remote review of records, video visits and interviews, and verbal interactions between the auditors and site personnel. The new guidance specifically discusses on-site audit procedures.
Although no formal guidance existed on the process followed by the FDA for GCP audits, over the last 50 years, there has been extensive collective experience in the industry about these audits. So, there are no surprises in the Guidance document. Most FDA audits are pre-announced to ensure that the key personnel at the facility are available to meet and interact with the FDA inspectors, the inspectors intend to spend as much time as needed for the review during the work hours for the site, the inspectors can review any documents that they deem necessary for the audit, the FDA inspectors provide an opportunity to discuss the nature of their request for documentation, and will discuss their observations with the staff.
An associated guidance document, released together with the GCP audit guidance document, describes the organization of the clinical site information in the eCTD for the ease of arranging GCP audits by the FDA. Specifically, that guidance asks for a “readily located” table listing all clinical sites that participated in clinical trials included in the application, and a list of all contract research organizations (CROs) involved in the clinical trials, along with subject-level data by clinical sites, and summary level clinical site datasets.
The new GCP guidance document is primarily designed as an introduction for new sites never audited before and to clarify any misperceptions. Its primary use would be as a training tool.
