Module 3qualitynda
3.2.R — Regional Information
Region-specific quality information (executed batch records, comparability protocols, methods validation)
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
Region-specific quality information (executed batch records, comparability protocols, methods validation)
Requirements by Phase
NDA: required
Content (NCE/Small Molecule)
- Region-specific quality information
- Executed batch records (where required by region)
- Comparability protocols (where required by region)
- Methods validation package (where required by region)
Expected Deliverables
- Executed batch records
- Comparability protocol
- Methods validation package
Source: 21 CFR 312.23(a)(7)
References
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.A — Appendices (Quality)
Quality appendices for biotech products: facilities, adventitious agents, novel excipients
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