Yes. According to [ICH Q7, Section 18.51], viral inactivation/removal steps are considered critical for some processes (e.g., cell lines of human and animal origin [ICH Q5A, Section 1]. Parameters for validation should be established in accordance with [ICH Q5A, Q5D and Q6B]. Due to the potential for contamination [ICH Q5A, Section 2.B], viral inactivation studies should be performed in a separate and typically smaller laboratory facility [ICH Q11, Section 7.2] and not in a clinical or commercial manufacturing facility.
