FAQ
Drugs

If a potential genotoxic impurity is formed or introduced prior to the final step of the API manufacturing process, under what conditions can one waive routine control of the potential genotoxic impurity in the drug substance specification?

刊登日期:2020-07-23  |  點閱次數 : 923 次 

A potential genotoxic impurity may be controlled in specifications of starting material, raw material, intermediate, or in-process control, but must meet at least one of the following conditions:

  1. 1. Acceptance criterion of the potential genotoxic impurity of API is specified at or below the acceptable limit of the impurity as stated in ICH M7 and analyzed using an appropriate analytical procedure.
  2. 2. Acceptance criterion of the potential genotoxic impurity of API is specified above the acceptable limit of the impurity as stated in ICH M7and analyzed using an appropriate analytical procedure. In addition, to assure that no additional controls in later process or final API are required, the understanding of fate and purge of the impurity in the following process should be provided. A spiking experiment which demonstrates the level of the impurity in the API is below 30% of the acceptable limit is recommended.
  3. If these conditions are not met, the potential genotoxic impurity has to be included in the API specification and controlled on a routine basis.
    (Referenced to ICH M7 and EMA/CHMP/SWP/431994/2007 Rev. 3 guideline)

(中文版)


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