2.3 — Quality Overall Summary

Quality overall summary covering drug substance and drug product (40-80 pages for NDA)

Requirements by Phase

IND Phase 1: minimal IND Phase 2: minimal IND Phase 3: minimal NDA: required

Content Requirements

• Summary following scope and outline of Module 3
• Drug substance: general information, manufacture, characterization, control, reference standards, container closure, stability
• Drug product: description/composition, pharmaceutical development, manufacture, control of excipients, control of drug product, reference standards, container closure, stability
• Emphasis on critical quality parameters and acceptance criteria
• Justification for any deviations from guidelines
• Cross-references to detailed Module 3 data
• Appendices and regional information as applicable

Expected Deliverables

• Quality Overall Summary document (40-80 pages)

Page guidance: 40 pages (80 for biotech products)

ICH Guidelines: ICH M4Q

Note: NDA: full 40-80 pages

Source: ICH M4Q

Cross-References: Covers quality data for both Drug Substance and Drug Product.