Elemental Impurities: The New Requirements
Duration: 90 Minutes
This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products. It will also provide detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results.
Objectives of the Presentation
Why Should you Attend
- Identify the various categories of impurities likely to be present in pharmaceutical products
- Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each
- Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form
- Report the results of testing consistent with expectations of regulatory agencies
Attend this webinar to understand in detail about general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities.
Who can Benefit
- Landscape of impurities requiring control in pharmaceutical products
- General impurities: elemental impurities, residual solvents, microbiological
- Drug-related impurities: process impurities, degradants, potentially genotoxic impurities
- Elemental impurities
- The case for change
- Current regulatory and compendial status, including EMEA Guidance, USP General Chapters and ICH Q3D
- Review of heavy metals USP <231>
- Understanding the coming requirements for elemental impurities <232>
- Scope, elements included, route of administration, limits
- Methods in <233> and alternative methods
- Strategies for compliance
Chemists, Supervisors and Laboratory Managers (Research, Quality Control, CRO) and Quality Assurance personnel involved with assuring conformance to elemental impurity requirements, and regulatory affairs/CMC personnel responsible for documenting compliance with elemental impurity and residual solvents requirements.