Private Third-Party Audits Could Enhance FDA’s Manufacturing Risk Analysis

Private and third-party audits could direct FDA to problematic facilities while easing some inspection burden on firms that already comply, but not replace FDA’s typical inspection duties.

The idea to better incorporate them into agency risk analysis, part of FDA’s Pathway to Global Product Safety and Quality plan, also will help the agency and other regulators step toward a system where one inspection satisfies all their requirements.

Murray Lumpkin, FDA deputy commissioner for international programs, said the agency has progressed toward that goal. FDA no longer just asks other regulators for reports, it now plans and conducts joint inspections and eventually could rely on others’ information.

“I don’t think any of us could put a time frame on [when we could get to] that. Some of the programs that we have under way are the stepping stones to get there,” Lumpkin said June 29 at the Biotechnology Industry Organization International Convention.

In May, FDA announced it was prioritizing collaboration in global supply chain security. Officials indicated the agency no longer could expect employees to conduct timely inspections of all foreign and domestic facilities and ensure they follow FDA standards (Also see "FDA Cloak And Dagger: GMP "Intelligence" Sought As Part Of Globalization Plan" - Pink Sheet, 15 Mar, 2011.).

The globalization plan, released June 20, confirmed the new global collaboration policy and said the agency eventually expects to rely on information gathered by other mature regulators to make its decisions (Also see "FDA Global Pharma Safety Plan Looks To Food Model" - Pink Sheet, 27 Jun, 2011.).

That could include the use of private contractors to conduct facility audits and other oversight activities. The globalization report states FDA plans to maintain “broad-based oversight of the entire range of products within its purview” through compliance and inspection programs that use public and private third parties.

FDA said in a statement it has not made a decision on what role public and private third-party inspections and audits will play in its strategy.

Contractors will not take over the agency’s inspection duties, noted Lumpkin, who will become FDA’s senior advisor and representative for global issues (Also see "FDA Becomes An Agency Of “Directorates” Under Hamburg’s Reorganization" - Pink Sheet, 18 Jul, 2011.).

“There is a move afoot now in this country to really look more and more at public-sector and private-sector third-party auditing as a way of not doing the job that FDA has to do, but as a way of feeding the information into this risk analysis,” he said.

“That is another source of good, valued information to help us make better decisions and particularly to help us figure out where we’re going to deploy the resources.”

Supplier Auditing Requirement Looks Possible

In the pharmaceutical excipient area, FDA appears to be laying the groundwork for a third-party auditing program in case the agency is required to audit those facilities.

While excipient manufacturer audits are not required by law, consultant Irwin Silverstein said FDA could rely on an IPEA audit to meet the needs of an agency visit.

Silverstein, chief operating officer of International Pharmaceutical Excipients Auditing Inc., which certifies excipient manufacturers comply with good manufacturing practices, said he expects FDA eventually to require manufacturers to audit their suppliers.

“We know that we relieve the burden of having to audit those companies that are certified,” Silverstein said in an interview.

“We would expect that the FDA would be perfectly satisfied on inspection for any pharmaceutical company who’s using a supplier who’s been certified to excipient GMP by” an American National Standards Institute-accredited third party.

FDA also is considering whether to adapt an internal inspector certification program for contractor use.

The agency has said it will need intelligence gathering capabilities to validate information received from private third parties. Improved data-sharing systems also would help the agency better allocate resources.

Foreign Collaborations Also Growing

FDA also plans to expand its facility inspection collaborations with foreign regulatory agencies to relieve some of its burden and identify supply chain vulnerability.

In a pilot program for drug product inspections FDA is collaborating with other regulators to share information. The agency said it could create a permanent collaborative process for drug product inspections once the pilot is completed.

A similar collaboration for active pharmaceutical ingredient GMP inspections, which began as a pilot program, became permanent this year.

FDA worked with the European Medicines Agency and Australian Therapeutic Goods Administration to disclose inspection locations, outcomes and other data for more than 1,000 sites.

The agencies also identified facilities where they shared inspection interest, presumably to determine where one agency could conduct an inspection suitable to satisfy the others’ needs (Also see "FDA-EMA-TGA Joint Inspection Program To Be Permanent; Other Collaborations Expand" - Pink Sheet, 21 Mar, 2011.).

Lumpkin said he wants the concepts in the pilot programs to become standard operating procedure for FDA. He also wants the agency to move from “confidence building” to “confidence in” the information gathered by foreign agencies.

“The glass ceiling is beginning to show cracks, going from just receiving to actually relying on it,” he said.

Ideally, the strategy will lead to less redundant inspections, such as separate visits by FDA and the EMA within a few months of each other.

Lumpkin also said the policy could mean fewer overall inspections at facilities that have good regulatory track records. He said a facility that has proven habitual compliance could be inspected every three to five years and those with chronic problems every six months.

“What some of us are actually even thinking about is raising the question, does every company need [an inspection] every two years?” he said.

FDA Foreign Offices Continue To Open

That aside, the agency continues to expand its foreign presence. FDA recently opened an office in Pretoria, South Africa, and is expecting to open an office in Amman, Jordan, in a few weeks.

The agency recently received approval to set up an office in Brasilia, Brazil.

President Obama made expanding foreign inspections and closer work with foreign governments one of his budget priorities for FDA in his fiscal 2012 budget request.

It was an indication that while the agency eventually plans to rely on foreign governments to share information and conduct inspections in the long term, in the coming years it still will need a presence for the bulk of its ex-U.S. work (Also see "FDA Globalization Efforts Gain Traction Even As Budget Request Emphasizes Old Inspection Model" - Pink Sheet, 21 Feb, 2011.).

[Editor's note: This article appears courtesy of "The Pink Sheet," Elsevier Business Intelligence's source for pharmaceutical and biotech industry news. Register for a 30-day risk free trial.]

By Derrick Gingery, ,