FDA meeting on cGMP initiative rescheduled

APRIL 24–ROCKVILLE, Md.–The Food and Drug Administration’s Advisory Committee for Pharmaceutical Science Manufacturing will discuss the agency’s “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” initiative on May 21.

The new subcommittee’s initial task will be to discuss the direction of the Office of Compliance’s August 2002 proposal to incorporate up-to-date risk management and quality systems approaches into manufacturing regulations.

FDA will likely present the results of a six-month progress report, which includes detailed reports from various working groups. The agency also recently released a draft guidance on chemistry, manufacturing and controls comparability protocols.

So far, FDA has begun a new policy of having the review centers oversee GMP warning letters and has identified high-risk areas to prioritize inspections. FDA has also been performing an external audit of pre-approval and post-approval GMP programs.

The agency is considering creating dedicated “pharmaceutical inspectorate” to improve the expertise and uniformity of inspections. The initiative also proposes getting the centers more involved in the process, including sending reviewers on inspections.

The mandate of the manufacturing subcommittee will also be discussed. This will be its inaugural meeting.

FDA had originally planned to discuss the cGMP initiative on March 21, but cancelled the meeting due to the start of the war in Iraq.

On May 22, the subcommittee will discuss aseptic manufacturing and process analytical technologies.


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