FDA's newly formed Council on Pharmaceutical Quality will oversee implementation of the agency's pharmaceutical current good manufacturing practices initiative for the 21st century.

"The agency has formed a Council on Pharmaceutical Quality, which has been charged with policy development, coordination, and continuing change management, including the ongoing implementation of specific quality management systems within the FDA," the Sept. 29 ¹ cGMP final report says.

The report's release caps a two-year effort at FDA aimed at improving manufacturing practices and reviews (² [A#00640340001], p. 3). The initiative was driven by the agency's cGMP steering committee, which will be succeeded by the council.

The council will be chaired by Acting Deputy Commissioner for Operations Janet Woodcock, MD, and will include up to four representatives each from the Center for Drug Evaluation & Research, Center for Biologics Evaluation & Research, Center for Veterinary Medicine, Office of Regulatory Affairs, and the Office of the Commissioner, including the Office of the Chief Counsel.

Council meetings are scheduled to begin in October and are expected to occur monthly.

In addition to the creation of the pharmaceutical quality council, internal changes resulting from the GMP initiative include a reorganization of CDER's Office of New Drug Chemistry (see ³ Also see "FDA Creates Four New Drug Chemistry Divisions For CMC Evaluation" - Pink Sheet, 4 October, 2004. ).

FDA released five guidances and several related documents along with the GMP initiative final report (see chart: " ⁴ GMP Paper Trail ").

The "Quality Systems Approach to Pharmaceutical cGMPs" draft guidance "describes a comprehensive quality systems model that manufacturers could use," the final report says. FDA also added a section entitled "Quality System Framework for Internal Activities" to its staff manual.

The final guidance on "Sterile Drug Products Produced by Aseptic Processing cGMPs" replaces 1987 guidelines.

The aseptic processing guidance is aimed at ensuring "robust product protection through adequate design and control of equipment and facilities" and "that the operational and raw materials inputs are predictable through adequate quality control and quality assurance," FDA said.

A Process Analytical Technology guidance "describes a regulatory framework that will encourage the voluntary development and implementation of innovative approaches in pharmaceutical development, manufacturing, and quality assurance."

FDA expects the PAT guidance to facilitate the introduction of new technologies to improve efficiency and effectiveness of the manufacturing process. "Several PAT proposals have been received, and it is expected that many of these will be received as applications in the near future," the final report says.

One draft guidance describes what manufacturing regulations must be followed in combination product development.

The draft guidance on "Computerized Systems Used in Clinical Trials," when finalized, will replace an April 1999 guidance. It will align FDA's thinking on the topic with policy articulated in the Part 11 electronic records and electronic signatures guidance (⁵ Also see "NDA Reviews Will Be Risk-Based Under FDA Good Manufacturing Initiative" - Pink Sheet, 27 September, 2004., p. 27).

GMP Oversight Will Have FDA-Wide Coordination Under Rx Quality Council

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