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1.1.1 CPMP – Position Paper on the Limits of Genotoxic Impurities –2002 1.1.1.1 Scope/Introduction
ОглавлениеWithin the introduction to the position paper, it was made clear that the need for such guidance was due to the fact that control over levels of genotoxic residues was not adequately addressed through existing ICH guidance.
The position paper consists of a series of sections that addressed the issue of genotoxic impurities from both a toxicological and quality perspective. The key points from those sections are described below.
