90% of GMP audit focuses on doc review, interviews, 483 prep, close out.

WASHINGTON -- The typical FDA GMP inspection approach focuses 90% on documentation review, interviewing key personnel, preparing a 483, if needed, and the close out meeting. Only 10% of the inspection focuses on other items, such as a site tour, observation of personnel behavior and performance, physical inspection of systems/equipment and review of logbooks, drug industry executives noted here March 27.

Dan Barreto, international VP of GMP compliance at Janssen Pharmaceutical, also noted at the Food and Drug Law Institute's (FDLI) annual meeting that advancing technology is causing a trend towards "virtual" inspections that are off-site, global oriented, performance-based, and electronic.

Added Gregory Hockel, VP of regulatory affairs at Pharmatech, Denver, CO: "Technology is a way to increase the transparency of the drug development process, and to establish trust among contributing parties."

A more virtual approach to inspections utilizing technology would allow "flexible and effective coverage of more companies, domestic and foreign under its current risk-based approach," he said. This also would allow industry the "ability to manage FDA inspections using smaller numbers of resources and under minimal disruptions." Technology minimizes activities on the "critical path" of approval.

For example, some of the activities that could be done virtually in the critical path area are compliance with GCPs, IRB approvals, signed informed consent forms, drug accountability records and protocol violations. The site inspection would then focus on source document verification. Similar concepts can be adapted to GLP and GMP inspections.

"This leads to increased compliance and greater patient safety," Hockel said.

Technology can increase the transparency of the drug development process. Many tools are available that allow project teams access to development activities in real time. These include:

* Electronic data capture (EDC)

* Clinical trial management systems (CTMS)

* Electronic trail master files (eTMF)

Types of information available from EDC systems are:

* Enrollment rate

* Screen failures

* Protocol violations/deviations

* Response data

* Serious adverse events

He added that types of information available from CTMS or eTMF are site documents, IRB approvals, protocol amendments, informed consent documents and monitoring trip reports.

"Having transparency and real time access to data/progress of the study can help establish trust and confidence," Hockel said.

This will occur at the sponsor level among senior management and staff, and with the sponsor and service provider. At FDA, trust and confidence in your program will be built with the Bioresearch Monitoring Group and reviewers. Also, it allows for corrective actions to be taken in real time.

Continuous review of electronic common technical documents (eCTD) would provide for an extension of rolling review for all NDAs, and PDUFA review time would focus on new information only, Hockel added.