Subcommittee will discuss cGMPs, aseptic processing

FEB. 6–ROCKVILLE, Maryland–The Food and Drug Administration’s Pharmaceutical Science Manufacturing Subcommittee will consider the Office of Compliance’s “Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach” guidance document during its March 21 inaugural meeting.

The new subcommittee will receive an update on regulatory approaches regarding aseptic manufacturing and discuss the direction of FDA’s initiative to incorporate up-to-date risk management and quality systems approaches into manufacturing regulations.

As part of the agency’s systematic reappraisal of product quality regulation, the FDA will develop a method of allocating resources commensurate with risk potential and evaluate the pre-market CMC review process and cGMP requirements as an integrated system.

Immediate steps for the program include a scientific/technical review of all drug cGMP warning letters and involving product specialists as part of inspection teams.


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