FDA Pilots New Quality Assessment System

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The US Food and Drug Administration (Rockville, MD) is looking for 12 pharmaceutical companies to take part in a pilot program designed to develop guidance for a new quality assessment system.

Participating companies will be asked to submit chemistry, manufacturing, and control information to be used as a demonstration of their “quality by design, product knowledge, and process understanding of the drug substance and drug product in a new drug application.”

The Office of New Drug Chemistry (ONDC) in the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, is expected to use the information gained from the pilot program to establish a modern, risk-based pharmaceutical quality assessment system, as described in a September 2004 white paper entitled, “ONDC's New Risk-Based Pharmaceutical Quality Assessment System.”


The new quality assessment system will focus on critical pharmaceutical quality attributes (related to chemistry, formulation, manufacturing process design, and product performance) and their relevance to safety and effectiveness. The principles underlying this new quality assessment system can be found in the February 2005 International Conference on Harmonization (ICH) draft guidance entitled, “Q8 Pharmaceutical Development.”

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