Application of quality risk management in GMP quality system for the manufacturers
XIAO Jiang-yi
PING Qi-neng
Abstract：Quality risk management (QRM) is a systematic process for the assessment, control, communi-cation and reviews of risks to the quality of the drug products across the product lifecycle. In the GMP implementa-tion, in order to insure the product quality effectively, pharmaceutical manufacturers should use QRM tool to analy-ses process and deviations, and to identify high risk process and critical process. In this article, we discussed the content of QRM, and identified how to integrate QRM into GMP quality system for the manufacturers.
Keywords：quality risk management (QRM)manufacturer of drugsgood manufacture practice (GMP)
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2102-2105 )