Regfo
Module 3qualitynda

3.2.A.2 — Adventitious Agents Safety Evaluation

Adventitious agents safety evaluation for biotech products

Requirements by Phase

Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
conditional

Adventitious agents safety evaluation for biotech products

Requirements by Phase

NDA: conditional

Content (NCE/Small Molecule)

  • Risk assessment for adventitious agents
  • Non-viral adventitious agents assessment (TSE, mycoplasma)
  • Viral safety studies
  • Viral clearance validation studies

Expected Deliverables

  • Adventitious agents risk assessment report
  • Viral safety evaluation report
  • Viral clearance validation study report

ICH Guidelines: Q5A, Q5D

Regulatory Requirements (FDA IND PHASE 2 3 CMC)

  • [Phase 2] Process controls that ensure performance of safety-related manufacturing steps (e.g., viral or impurity clearance) for fermentation and natural source drug substances should be clearly described.

Note: Biotech only

Source: ICH Q5A; ICH Q5D

References

ICH Q5AICH Q5D

Related Sections

Up to3.2.A — Appendices (Quality)
3.2.A.1 — Facilities and Equipment

Facilities and equipment description (applicable to biotech products)

3.2.A.3 — Novel Excipients

Safety data package for novel excipients

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