June 5, 2006

The FDA's decision to withdraw seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative is a sign that the agency is serious about updating its approach to cGMP and taking a more global view of regulations, industry sources say.

The agency withdrew several Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research guidances because of inconsistencies with its Pharmaceutical Current Good Manufacturing Practices for the 21st Century initiative. In the meantime, the FDA is recommending that the drug industry use International Conference on Harmonisation (ICH) documents as a guide to manufacturing practices.

The move is being lauded by industry sources that say the agency's previous manufacturing standards had focused too little on risk-based decisionmaking.

The agency's approach to GMP had been "overly prescriptive," representing "overkill in a check-the-box mentality," Janeen Skutnik, Pfizer's director of compendia affairs and regulatory monitoring, told FDAnews.

The agency's suggestion for industry to use ICH documents is also another sign that the FDA is moving toward a global approach to regulation, Skutnik said.

But companies will face short-term compliance problems through the agency's actions, Gordon Richman, vice president of strategic compliance and general counsel of the consulting firm EduQuest, said.

Industry faces a learning curve for two reasons, Richman said. First, the move from a quality assurance approach to the FDA's new quality systems approach is an "evolutionary step" in risk management, requiring significant infrastructure changes for companies.

For example, the FDA now expects company management to be more involved in ensuring proper manufacturing practices. Industry needs to change their infrastructure to ensure this greater involvement, Richman said.

Some companies are "mistakenly sitting back" waiting for amendments to the cGMP regulations before taking steps to comply with the initiative, he said. (http://www.fdanews.com/did/5_108/)