FDA's Update on Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines - Are you ready?
Duration: 90 Minutes
New, dramatically different requirements for elemental impurities will soon be introduced for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Objectives of the Presentation
Why Should you Attend
- How the new FDA Guidance on Elemental Impurites is related to ICH Q3D and USP Chapters 232 and 233
- What drug products are within the scope of the guidance
- Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
- How risk assessment influences what testing is required
- What documentation related to control of elemental impurities is expected by FDA
- Which procedures can be used to demonstrate compliance
- How methods should be validated
FDA has issued a Draft Guidance on Elemental Impurities in Drug Products, which addresses ICH Q3D and USP General Chapters 232 and 233 on this topic. The Guidance makes recommendations on how to submit NDAs or ANDAs for non-compendial drug products, and how manufacturers of compendial drug products can comply with the new requirements. The similarities and differences between ICH Q3D and USP 232/233 are discussed, and recommendations are made for different categories of drug products, including compendial and non-compendial, and those approved under an NDA/ANDA or not approved under an NDA/ANDA. A risk-based approach to the control of elemental impurities is advocated, which informs which elements are likely to be present and what controls are appropriate. The guidance also addresses validation of analytical procedures and early adoption of the standards.
Who will Benefit
- Elemental Impurities: The case for Change
- Overview of Guidance Documents: FDA, ICH Q3D, USP 232/233
- Scope of the guidances
- Risk Assessment
- FDA Recommendations
- Controls and Documentation
- Analytical Procedures and Validation
- What you should be doing now
Pharmaceutical R&D and QC chemists and their managers; Regulatory Affairs personnel, including those responsible for filing NDAs and ANDAs or other drug products and those responsible for Annual Reports and updating analytical methods and specifications. Individuals at Contract Manufacturing and Contract Laboratory facilities should also attend.