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The guideline stipulates:

1 The mutagenic impurity classification and rationale for this classification, for actual and potential process‐related impurities and degradation products, needs to be provided. Particular emphasis is placed in the guideline on the need to justify the classification of impurities into Class 4 and Class 5 impurities.

2 When bacterial mutagenicity assays were performed on impurities, study reports should be provided for bacterial mutagenicity assays on impurities. What is not clear is whether or not this should be included directly in the submission in the relevant section (would this be within the preclinical section or S3.2 Impurities?) of the dossier or as a supplementary reference.

3 Justification for the overall control strategy and any proposed specification. For Option 3 and Option 4 control approaches, a summary of purge factors and identification of factors providing control (e.g. process steps and solubility in wash solutions) needs to be provided.

Within both later stage clinical applications and the Common Technical Document (CTD), there is an explicit need to properly articulate and justify the classification of impurities based on SAR and any subsequent bacterial mutagenicity data. One potential option would be to include a summary table.