Q. QUALITY CHANGES – Q.II. FINISHED PRODUCT – Q.II.h) Adventitious Agents Safety

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Valid Version — C/2025/5045 (effective 16.01.2026)

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Q. QUALITY CHANGES – Q.II. FINISHED PRODUCT – Q.II.h) Adventitious Agents Safety

Q.II.h.1 Update to the ‘Adventitious Agents Safety Evaluation’ information (Section 3.2.A.2)

#qiih1

Q.II.h.1 Update to the ‘Adventitious Agents Safety Evaluation’ information (Section 3.2.A.2)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) Studies related to manufacturing steps investigated for the first time for one or more adventitious agents			II
(b) Replacement of obsolete studies related to manufacturing steps and adventitious agents already reported in the dossier
1. with modification of risk assessment resulting in higher risk			II
2. with modification of risk assessment resulting in equivalent or lower risk		1, 2, 3	IB
3. without modification of risk assessment		1, 3, 4	IB
Documentation
1. Amendment of the relevant section(s) of the dossiers including the introduction of the new studies to investigate the capability of manufacturing steps to inactivate/reduce adventitious agents.
2. Justification that the studies modify the risk assessment resulting in equivalent or lower risk.
3. Amendment of product information (where applicable).
4. Justification that the studies do not modify the risk assessment.

Q. QUALITY CHANGES – Q.II. FINISHED PRODUCT – Q.II.h) Adventitious Agents Safety

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