MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES
MODULE 3: QUALITY:
3.S DRUG SUBSTANCE
- nomenclature
- structure
- general properties
- description of manufacturing process and process controls
- control of materials
- controls of critical stops and intermediates
- process validation and/or evaluation
- manufacturing process development
- characterization
- control of drug substance
- referente standards or materials
- container closure system
- stability
3.P DRUG PRODUCT
- description and composition of the drug product
- pharmaceutical development
- manufacture
- control of excipients
- control of drug product
- reference standards or materials
- container closure system
- stability
MODULE 4: NONCLINICAL STUDY REPORTS
MODULE 5: CLINICAL STUDY REPORTS
