A new, dramatically different requirement for elemental impurities is now required for most pharmaceutical products. These mandates cover more metals, but require lower limits than the antiquated “Heavy Metals test.” However, the analytical technique – ICP-MS – is much more challenging.
This subject is of importance to manufacturers of new drug products as they will be required to comply with these new elemental impurities standards either through thorough risk assessments or testing as new regulatory submissions are made. For manufacturers of existing products, implementing risk assessment and testing strategies required to demonstrate compliance with these new standards will be a major challenge. If the manufacturer’s compliance strategy involves testing, there are many things to consider regarding the selection of the correct analytical technique (e.g., atomic absorption, ICP emission spectroscopy, ICP mass spectrometry). By attending this course you will learn about the new requirements, how to implement them, and how to use robust risk assessment to minimize unnecessary testing and meet FDA expectations.
- Elemental Impurities: The case for change
- Regulatory status: FDA, ICH Q3D, USP 232/233
- Scope of the guidances
- Risk Assessment
- Implementation of the guidelines
- Analytical Procedures and Validation
During this interactive, 90-minute session you will learn:
- How the new FDA Guidance on Elemental Impurities 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