Pharmaceutical Inspectorate will follow 'team biologics' model, create PAT team: Web-based investigator training offered.

WASHINGTON -- "Team Biologics" brought a new inspection model to FDA, which included more specialized training and additional inspection guidance materials, including written SOPs for the team.

When Team Biologics began in 1997, the core team consisted of senior investigators who received blood-bank training, such as plasma fractionation, and were often joined by product specialists at the Center for Biologics, Deborah Ralston, director of FDA's Office of Regional Operations, told the California Separation Science Society's Well-Characterized Bio-pharmaceutical Products 2004 conference here Jan. 6.

"Now biopharmaceuticals are the focus of the team, and everyone has a drug background," Ralston said, adding that the way they operate "has dovetailed nicely into the agency's GMPs for the 21st Century Initiative." In fact, the "Pharmaceutical Inspectorate is an outgrowth of the Team Bio concept," Ralston noted.

Team Biologics has inspected about 170 facilities to date, Ralston said. The core team consists of 13 investigators and three compliance officers, which "are assigned to headquarters but work in the field closely with CBER," she added. A newly created "team leader" position serves as a liaison and helps plan work activity, meeting monthly with the Center and weekly with other team leaders, she said.

Assigned inspections are getting completed on time, and the team is meeting its inspection frequency goals. The team did not attain all the product categories until two years into the process, Ralston said, and so it took five years before a formal evaluation could be completed.

With the transfer of therapeutics from CBER to the Center for Drugs, the agency plans to move therapeutics under the drug compliance program, which is more "traditional," Ralston said.

She reported that 30% of the inventory the core team currently inspects consists of therapeutics, and the group has been mapping out how responsibilities will be divided. She said the field committee will start working with the Centers to be more systems based, following the Team Bio model.

Team Bio has evolved, Ralston said, and is "finally doing investigator certification." Several investigators have Level II specialization training, and four of the team members have been identified as performance auditors (who will audit those seeking Level II certification), according to Ralston.

Additionally, the core team will become adjunct members in the Pharmaceutical Inspectorate in therapeutic areas. Ralston said the core team would remain "Team Bio," while the cadre of 165 investigators who did blood-bank inspections would remain under the field umbrella. She said this cadre will be trained on both large and small molecules to keep the group consistent.

The Inspectorate has begun training for process analytical technology (PAT) and, like Team Bio, will be geographically spread across the country to be pulled in as needed, said Susan Setterberg, regional director of FDA's Central Region, in a later session.

"We needed flexibility in the field to call on high-tech people when we needed them. We're bringing a few people together, for example with PAT, which will serve as a good model for developing the inspectorate," she said.

The desired goal for the inspectorate, Setterberg said, is to have a "highly trained group that focuses the majority of their time on conducting human and animal drug quality inspections on high-risk firms." She said other activities would include analysts in the laboratory training other FDA people and working with CDER to share ideas. She stressed the collaborative effort that was the essence of the Inspectorate.

Setterberg said the current position descriptions "are appropriate" and the "certification program could be expanded." She said FDA has been building certification in the drug area, similar to the Center for Devices certification program.

"Two years ago, counterterrorism efforts enabled FDA to expand the field certification program to a new level with web-based training," she said, and the agency plans on making similar web-based courses available to anyone. "For FDA and states, it's free; there will be a fee for industry, but it allows industry to see what investigators are trained on," Setterberg reported.

To keep current, Inspectorate investigators need to spend 25% of their time in specialist areas and will need management's endorsement. Currently, CDER has 77 packages to review for Level II certification, Setterberg said.

"We hope to have at least 100 people available all the time," she said. "They also have to successfully undergo an audit by a senior investigator to be Level II auditors. This should raise the level of consistency, which is one of the successes of Team Bio." She added that she hopes the training program will help in this area as well.

As the industry moves toward adopting PAT, the PAT team will expand out into Level III nominations, and Setterberg said the agency has just designated a fourth auditor, who will begin auditing the Level II packages. She said she doesn't expect to have everyone at Level III certification "any time soon." About 20 people have submitted applications to be Level III specialists, and she estimated that there are about 30 people in the field who could become Level III specialists.

The Level III certification is "brand new," taken directly from FDA's GMP initiative, so the curriculum is still being developed, Setterberg explained. She said she hopes to have about 50 Level III people in the inspectorate by 2007. The director added that firms should not expect to always get a Level III investigator. Also, the Inspectorate should not affect the number of inspections, but could affect the time spent at a firm.