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FDA Quality Systems Guidance Suggests “Trending” For Batch Testing

Executive Summary

A quality systems approach to manufacturing should include continual monitoring and analysis of trends in batch quality, FDA's quality systems draft guidance states

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FDA's "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices Regulations" final guidance does not call for annual internal audits of quality systems

FDA manufacturing GMP documents

FDA plans to issue final quality systems guidance by summer, FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb says March 14 at the International GMP Conference in Athens, Ga. The September 2004 draft guidance, which was part of FDA's final report on its Pharmaceutical cGMP Initiative for the 21st Century, calls for regular analysis of trends in batch quality (1"The Pink Sheet" Oct. 4, 2004, p. 20). FDA also plans to complete a report summarizing "the work of our risk management work group, which was charged with identifying continuous improvements in the risk model for prioritizing sites for manufacturing inspections," Gottlieb adds...

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