About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 14 December 2023
Replaces: ICH Topic Q5A (R1) - Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin (ICH Q5A(R1); CPMP/ICH/295/95)
Categories: ICH | Quality
Biologicals | Finished product | Adventitious agents safety evaluation
TGA annotations:
The following change is to be applied to the guideline: Table 4 Case B – Test for virus in purified bulk – yesj; j. The absence of detectible virus should be confirmed for purified bulk by means of suitable methods having high specificity and sensitivity for the detection of the virus in question. For the purpose of marketing authorisation, data from at least 3 lots of purified bulk manufactured at pilot-plant or commercial scale should be provided. However, for cell lines such as CHO cells for which the endogenous particles have been extensively characterised and adequate clearance has been demonstrated, it is not usually necessary to assay for the presence of the non-infectious particles in purified bulk. Note: For marketing authorisation, typically RVLP quantification data from 3 lots or more of purified bulk at pilot plant scale or commercial scale should be provided.
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.