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This section has four Q&As, which relate to the following topics:

 Recommendations for validation and documentation to provide for in‐house or not commonly used(Q)SAR models.

 Expectations for qualification of an (Q)SAR “out of domain” or “non‐coverage” result to assign an impurity to Class 5.

 Ames negative impurities with positive clastogenicity study results.

 Rationale for follow‐up assays in Note 3.