FDA plans to release a concept paper in late February on technical dispute resolution as one update on its initiative to adapt risk assessment principles into good manufacturing practices for drugs and biologics.

The agency announced its plan for risk-based GMPs for drugs and biologics in August 2002 (¹ [A#00640340001], p. 3).

One of the short-term goals of the two-year initiative is creating a "technical dispute resolution process that integrates technical experts from the centers and addresses perceived inconsistencies between centers."

FDA also plans to provide details on implementation of several other short-term goals, including use of product specialists as part of inspection teams, improvements to "Team Biologics," communicating deficiencies to companies and sponsoring scientific workshops.

Members of the agency's steering committee, who were appointed last year to oversee the initiative, have been meeting on a weekly basis since the August 2002 announcement and have formed 14 sub-groups.

One sub-group on "Work Planning and Risk Management" is looking at the long-term goals of applying risk management principles to the agency's GMP programs, specifically resource allocation.

FDA Office of Compliance Director David Horowicz and Associate Commissioner for Planning & Evaluation Theresa Mullin, PhD, co-chair the work planning and risk management group, which generally meets weekly. Between 10 and 20 staffers participate in each of the sub-groups.

One short-term goal of the initiative, shifting the agency lead on implementation of its electronic signature rule (Part 11) from the Office of Regulatory Affairs to the Center for Drug Evaluation & Research, already has been accomplished.

The Pharmaceutical Researchers & Manufacturers of America, which has formed its own work group to respond to the agency plan, has endorsed using the proposed Manufacturing Subcommittee to the Pharmaceutical Sciences Advisory Committee as a steering committee to implement the GMP plan (² Also see "FDA Manufacturing Subcmte. Should Track Industry/Agency Disputes – PhRMA" - Pink Sheet, 4 November, 2002., p. 35).

GMP Dispute Resolution Concept Paper From FDA Expected In February

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