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# Stakeholder Suggestions for IHC Q5A Guidance
- URL: https://www.fdaweb.com/stakeholder-suggestions-for-ihc-q5a-guidance/
- Published: 2023-01-18T12:00:00.000Z
- Updated: 2026-09-14T18:12:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153560

The Biotechnology Innovation Organization (BIO) recommends ways FDA could strengthen its International Council for Harmonization Q5A draft guidance on evaluating the viral safety of biotechnology products derived from cell lines of human or animal origin. The association’s comment [letter](mailto:https://www.regulations.gov/comment/FDA-2022-D-2512-0008) recommends that FDA:

- clarify the role/conduct of new molecular test methods for cell line qualification;
- provide further detail/examples on the application of risk assessments for viral contaminants;
- ensure examples are clear and consistent; and
- clarify opportunities to leverage previous experience/data.

BIO also provides specific line edits.

In its [response](mailto:https://www.regulations.gov/comment/FDA-2022-D-2512-0005), Pharmaceutical Research and Manufacturers of America says it generally supports the draft and believes it could benefit from greater clarity on several concepts and that language could be enhanced to better facilitate a shared understanding of the agency’s expectations related to viral safety testing and evaluations. The association also provides specific comments.