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ICH Q3D recommends a science and risk-based approach to evaluate the potential for introduction of EIs into the drug product and to determine if additional controls need to be included in the overall control strategy to ensure product quality and safety. The overall process follows the sequence identify, evaluate and summarise.

Product Details

Edition:

1st

Published:

07/29/2020

Number of Pages:

53

File Size:

1 file , 2.9 MB