US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but said it could be improved by incorporating continuous manufacturing principles and clarifying materials testing recommendations.
These comments were made in response to FDA’s release of the Q5A(R2) guideline for public comment in November 2022. The deadline for comments was 13 January.
The guideline sets harmonized scientific and technical requirements for evaluating the viral safety of biotechnology products. The document also encourages sponsors to use alternative tests, such as Next Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) which aligns with global initiatives and reduces the reliance on animal tests…
