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As highlighted earlier the guideline noted that risk assessment of manufacturing processes should be undertaken to identify potential MIs

and that impurity structures should be risk assessed (using in silico systems that link structural motifs to potential toxicological responses). This sounds very reasonable and practicable. However, one could find two “experts” in the field who might draw up two different lists of potential impurities associated with a particular manufacturing process. The challenge is one of defining what is considered reasonable when defining impurities, particularly MIs. Within the framework of the original guideline, it was also unclear as to how many steps within a process should be taken into consideration when performing such an assessment. This was a specific topic returned to when the ICH M7 [1] guideline was elucidated.