Module 3qualityndaind
3.2.A — Appendices (Quality)
Quality appendices for biotech products: facilities, adventitious agents, novel excipients
Requirements by Phase
Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
required
Quality appendices for biotech products: facilities, adventitious agents, novel excipients
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required
Content (NCE/Small Molecule)
- Quality appendices: facilities/equipment (biotech), adventitious agents safety evaluation, novel excipients
Expected Deliverables
- Quality appendices package
ICH Guidelines: Q5A, Q5D
Source: ICH Q5A; ICH Q5D
Sections
Related Sections
Up toModule 3: Quality3.2.S — Drug Substance
Drug substance quality information: characterization, manufacture, control, reference standards, stability
3.2.P — Drug Product
Drug product quality information: composition, development, manufacture, control, stability
3.2.R — Regional Information
Region-specific quality information (executed batch records, comparability protocols, methods validation)
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