If metal catalysts are used in the manufacturing process of the drug substance, what data should be provided in order to waive routine control of such metal (elemental) impurities?

刊登日期:2020-07-22  |  點閱次數 : 919 次 

The acceptance criteria for element impurities should be established based on ICH Q3D; in order to waive routine test of residual elemental (the metal) impurities, one of the three following items should be provided:

  1. 1. Establishing reasonable acceptance criteria on a suitable intermediate.
  2. 2. Perform a purge study on the synthesis step in which metal catalyst was used, and provide analysis results of several batches to demonstrate that analysis results of residual elemental impurities meet acceptance criteria indicating that the use of metal catalyst can be effectively removed from the relevant manufacturing and analysis results meet acceptance criteria.
  3. 3. Demonstrate with a validated analytical method that the analysis results of residual elemental impurities on 6 consecutive pilot scale batches or 3 consecutive industrial scale batches are below 30% of the acceptable limits on a suitable intermediate or on the drug substance. Validation data of the analytical method should also be provided.




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