Overall cGMP revamp plan expected within four months

MAY 27–ROCKVILLE, Md.–The Food and Drug Administration’s Pharmaceutical Science subcommitee “expects to finish an overall plan” for an initiative that will revamp current good manufacturing practices (cGMPs) “within the next four months.”

“Topics that require further work by the steering committee include the definition of ‘quality’ for pharmaceutical products, risk assessment, the role of the CMC review function, and the current regulatory structure for quality management systems,” a progress report states.

The subcommittee is also likely to provide input on the criteria for evaluating the success of the working groups and the overall initiative.

FDA announced the “Pharmaceutical cGMPs For The 21st Century: A Risk-Based Approach” initiative in August 2002. The purpose of the two-year program is to create “a science and risk-based approach to product quality regulation, incorporating an integrated quality systems approach.”

FDA will present summary progress reports from the working groups and completed six-month milestones.

As of March, the agency centralized the review of all cGMP warning letters under the relevant Centers. A risk-management approach is already being used to prioritize inspections for higher-risk manufacturing sites. FDA plans to have the specialized “Pharmaceutical Inspectorate” underway by June, with 15-25 officers enrolled for FY 2004.

A public workshop on the GMP initiative was held in April, and recommendations from break-out sessions at the conference will be included in a report to be submitted to FDA.

FDA is seeking comments on the proposed three-stage dispute resolution process. The working group report recommends consideration of a short post-inspection delay in issuing 483 reports and a process to resolve internal disagreements within FDA.

The subcommittee is also expected to discuss FDA’s draft guidance on comparability protocols, which allows waivers for changes to manufacturing processes without submission of a prior approval supplement to FDA.

The working group on 483 reports has proposed additional standard language to be provided to the sponsor “to clarify the purpose and effect of the 483 and alert the recipient about how to object to an observation or how to bring new information to FDA’s attention.”

Other issues raised in the summary progress report include FDA’s Team Biologics program, the inclusion of product specialists on inspection teams and process analytical technologies.


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