All FDA GMP inspections are systems-based as of 2006: industry analyst.

As of 2006, all GMP inspections went to a systems-based model, which includes quality, facilities and equipment, materials, production, packaging and labeling, and laboratory systems, a senior industry analyst told a Feb. 14 ExpertBriefings.com audioconference.

Dennis Runser, Ph.D., TMI Regulatory Compliance Consulting, noted that this includes API and foreign inspections as well, and that an API compliance program for systems-based approaches was released by FDA last year.

He said that FDA's movement toward systems-based inspections provides numerous advantages to the industry over ones that previously were product-based, such as improved consistency with inspections and EIRs. Plus, the approach provides benchmark standards of operating efficiencies to industry and is more in line with fundamental business concepts of management.

However, Runser noted many companies are still resistant to switching over to a systems-based concept on inspection. "This is due to lack of upper management commitment and a company culture issue," he said.

Corporate inertia, resistance to change and lack of executive management support also are problems in systems-based inspections.

He argued that there may be a need for additional regulations to "force people's hands" and make them adopt systems-based quality systems. However, he said, "the political winds in Washington have not been favorable to additional FDA regulations, so the agency has favored the guidance approach."

Runser stressed that additional regulations are not necessary, and that "a systems-based approach to running a company is the most efficient way to go."

He told the briefing that some of the pitfalls that impede systems-based inspection include the following:

* The check list mentality;

* Assumption that no 483s means there are no problems;

* Vendors who "work under the euphoria" that no 483s means they are something special;

* Lack of a good change control program;

* No formalized corrective and preventive action (CAPA) program;

* No metrics systems for tracking and trending deviations, out-of-specification (OOS) results and non-conformances.

He explained that some quality sub-systems include batch, disposition, process validation, warehousing and technology transfer.

Laboratory quality sub-systems are OOS/retesting/resampling, instruments/equipment qualification and methods transfer. Other quality subsystems include internal audits, CAPA and complaints.

"System-based solutions to identified quality problems don't happen often because solutions have to cross department lines," the analyst added. Quality does not have the authority to act systems-wide.

Self-disciplined teams with no one really in charge to champion the group or program also is a problem, he said.

"Also, systems-based problems often are identified but no one acts to correct problems globally."

Runser provided some tips to ensure that systems-based auditing is integrated into an organization:

* Make sure the quality department does their reports in systems-based language;

* Provide management with monthly quality metrics which address systems matters;

* Have a solid change control program;

* Have a formalized CAPA program integrated into the change control program; and

* Establish a point of authority who is directly involved. Story by Joe Pickett

A CD recording of Runser's talk and his outline are available from ExpertBriefings.com for $295--for Inspection Monitor subscribers only. Just call (703) 779-8777 to order, or email service@ExpertBriefings.com