ICH Q10 may replace FDA's Quality System guidance

Executive Summary

FDA official Diana Amador-Toro reported that the ICH guideline is "a model for an effective quality system" and is necessary to harmonize the "divergent approaches to quality systems across regions and to correct suboptimal deployment of resources by both industry and regulators." It is also needed to correct the "inconsistent approaches to compliance inspections," she noted on July 24 at the Pharma Conference. Amador-Toro is on the committee negotiating ICH Q10, which was approved as a Step 2 guidance in the U.S. and the EU in May. It is unclear whether it has yet been approved in Japan; Amador-Toro noted that translation problems may be delaying its approval there. The guideline focuses on management responsibility of the quality system, continual improvement of the process performance, and continual improvement of the pharmaceutical quality system. Amador-Toro said that she was "amazed at the [quality system] differences between the three regions. [The guideline] shows our common commitment to quality and encourages a preventive action culture." Amador-Toro reported that the ICH expert working group will start to work on a Step 3 guidance in June 2008 after the close of the public comment period for the Step 2 guidance. "I encourage you all to submit your comments," she told meeting participant