About course section
Description:
ICH Q3B(R2) – Impurities in New Drug Products provides regulatory guidance for identifying, reporting, and controlling impurities that arise from degradation or interaction between the drug substance and excipients/container systems in finished pharmaceutical products. It complements ICH Q3A (dealing with drug substance impurities) and Q3C (residual solvents) and focuses on ensuring patient safety throughout product shelf-life.
Key Highlights:
1. Scope & Focus
- Targets only degradation-related impurities in chemically synthesized new drug products. Excludes biologicals, excipient/extractables, polymorphs, enantiomers, and contaminants from poor manufacturing
2. Reporting, Identification, Qualification Thresholds
- Defines tiered thresholds based on the maximum daily dose:
- Reporting threshold: new or significant degradation products above 0.05–0.1% (w/w)
- Identification threshold: higher threshold requiring structural characterization (0.1–1% depending on dose)
- Qualification threshold: above which safety/toxicological qualification is required
3. Analytical Requirements
- Analytical procedures must be validated for specificity, sensitivity, and quantitation, including forced degradation testing (stress conditions)
4. Batch Data & Documentation
- Regulatory filings must include impurity data from clinical, development, and commercial scale batches—presented numerically, annotated with analytical methods and chromatograms
5. Specification Inclusion
- Specifications must list identified and unidentified degradation products with defined acceptance criteria, based on batch data and stability studies
6. Qualification Strategy
- Requires safety justification for degradation products exceeding thresholds—drawing on clinical batch exposure, literature, or additional studies, guided by a decision-tree in the guideline
What you will learn:
- How to evaluate and summarize degradation pathways and degradation products through stability studies.
- To apply tiered thresholds for reporting, identifying, and qualifying impurities based on drug dosage.
- Techniques for validating analytical methods, including forced degradation approaches.
- How to compile comprehensive batch impurity data and chromatograms for submissions.
- Best practices for setting specification limits for both identified and unspecified impurities.
- Strategies for degradation product qualification, including use of safety/tox data and decision-tree logic.
Trainer - Iva Dhulia
With a Master’s degree in Pharmaceutics and a regulatory career spanning since 2009, Iva Dhulia brings over 15 years of global experience across the US, EU, and ROW markets. Her core strengths lie in CMC document review, dossier compilation, lifecycle management, and cross-functional collaboration.
Since joining ISAZI in 2020, Iva has played a pivotal role in regulatory strategy and submissions. She also contributes to ICH training programs, offering a hands-on, submission-focused perspective that helps professionals apply regulatory knowledge with confidence and clarity.
🌍 Passionate about regulatory excellence, Iva is committed to bridging knowledge and practice for successful product registrations worldwide.