Investigational
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Our Novartis policy regarding (geno)toxic impurities<br />
NOVARTIS<br />
We have introduced a new policy regarding the detection, testing,<br />
elimination and risk assessment of potentially (geno)toxic<br />
impurities in drug substances or drug products<br />
In general, the procedure starts with a “Computational toxicology<br />
assessment of every drug substance synthesis scheme”<br />
‣ Why?: focus on toxicological knowledge and informed decision making<br />
Product of this assessment and the interaction between<br />
chemistry and toxicology is a “Notification on the presence of<br />
unacceptable substances in synthesis” before Phase I trials.<br />
‣ This “Notification” is constantly updated throughout the development process<br />
‣ The “Notification” includes actions and measures regarding purity, limits<br />
based on toxicity and scientific rationales on these limits<br />
The new policy is described in a new world-wide SOP:<br />
“GENERATION OF THE SYNTHESIS SCHEME AND COMPLETION<br />
OF THE SYNTHESIS CONTROL FORM AND NOTIFICATION FORM<br />
FOR KNOWN AND POTENTIAL IMPURITIES”<br />
L. Müller, Swissmedic, 21-Oct-2003
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