Video

The ICH Q5A Revision, Its New Scope And Guidance

The ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin was recently published for public comment.

In addition to therapeutic proteins and plasma products, genetically engineered viral vectors and viral vector-derived products are in scope. This is only if viral clearance methods do not have a negative impact on the quality of the product. Specific guidance on these products is also included.

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