Regulatory Beat: FDA's Field Force Does More With Less - Team model extends from biologics to drugs as ORA leadership seeks to transform inspection system - BioPharm International


Regulatory Beat: FDA's Field Force Does More With Less
Team model extends from biologics to drugs as ORA leadership seeks to transform inspection system

BioPharm International
Volume 19, Issue 6

Most biotech manufacturing operations fall into the high-risk category because they involve sterile injectables and production methods susceptible to contamination. CDER is adopting this model to identify 500 domestic production facilities that fall into the high-risk tier and should be inspected by ORA this year. This group will account for about half of ORA's drug inspections for 2006, with the rest based on the need for a pre-approval inspection, a recall or complaint, or follow-up to a previously unsatisfactory inspection. District inspectors more familiar with specific plant operations have discretion to add or remove certain facilities on the priority list.


In addition to targeting inspections to high-risk operations, ORA is implementing other strategies to streamline the inspection process. FDA's Good Manufacturing Practices (GMPs) for the 21st Century Initiative, launched to encourage risk-based approaches to compliance and adoption of quality production technologies, has established several new approaches for GMP inspections. One initiative has given Centers more input in issuing warning letters for GMP violations identified during inspections; another seeks to better integrate pre-approval and GMP inspections.

An important development has been to extend the team inspection approach pioneered by Team Biologics to drugs and other medical products. ORA is establishing a Pharmaceutical Inspectorate of specially trained experts able to audit complex drug products and facilities. However, Team Biologics retains responsibility for inspecting manufacturers producing biotech therapeutics now regulated by CDER, as well as for biologics and blood establishments in the Center for Biologics Evaluation and Research (CBER).

For pre-approval inspections, CBER compliance staffers continue to take the lead in this area. And now a similar approach has been adopted by CDER for biotech products, explained Brenda Uratani of CDER's Office of Compliance (OC) at a recent conference on biotech regulation sponsored by Pharma Conference. Product specialists from OC's branch overseeing biotech therapeutic facilities and from CDER's Office of Biotechnology Products who review biotech process manufacturing controls now have lead responsibility for conducting pre-approval inspections for biotech therapeutics in CDER. FDA is incorporating this model of more ORA–Center shared responsibility in revising inspection approaches for drugs. Team Biologics and the Pharmaceutical Inspectorate are "the future" of federal GMP inspections, Glavin comments.


While FDA seeks to streamline the frequency and scope of its field inspection program at home, it is struggling to cope with a rising number of foreign-based inspections. FDA conducts about 1,000 foreign inspections for drugs and biologics each year, but this program, unfortunately, now is only the tip of the iceberg. More than 30 foreign regulatory agencies now want to inspect pharmaceutical manufacturing plants, and the number continues to increase, according to Malcolm Holmes, director of global quality assurance at GlaxoSmithKline. Industry is building large, sophisticated production facilities that may export products to more than 80 different markets, and inspectors from all over the world are showing up to conduct their own audits. This kind of "industrial tourism" does little to enhance public health and safety, Holmes stated, noting that industry now spends some 35,000 person-hours coping with multiple foreign inspectors from Mexico, Argentina, Africa, and Asia.

International adoption of risk-based inspection models and more sharing of information offer prospects for relief. Although no one is looking for mutual recognition of inspection decisions by foreign agencies, there is growing interest in bilateral agreements for sharing inspection information among regulatory authorities. US membership in the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which is moving forward, could expand acceptance of PIC/S certificates to include that a plant also meets GMP standards. Foreign regulators could save resources by first examining what inspection report information is available from PIC/S, from FDA's inspections database, and from an EU database currently under development. Clarification by the World Health Organization of its recommendations for when plant inspections are needed would be helpful. Manufacturers with sound GMP compliance histories and corporate integrity programs also may gain some regulatory relief if foreign regulatory authorities accept such quality assurance policies as indications of compliance.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

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