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
The subject is of importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing as new regulatory submissions are made, and to manufacturers of existing products as they make decisions regarding the extent of risk assessment and testing required to demonstrate compliance with the new standards. 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).
The objective of this live training webinar is to provide an understanding of the new standards and guideline, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.
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
- Researchers/ R&D Mangers
- Laboratory Managers/ Directors / Supervisors
- Laboratory Technicians / Operators
- Analytical Chemists
- Laboratory Managers
- Regulatory Compliance Managers
- Quality Control and assurance managers
- Chemical Manufacturing and Control managers
The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products will be implemented on January 1, 2018. General Chapters <232> and <2232> specify the list of elements and their permissible daily exposure (PDE) limits based on the route of administration.
USP has now harmonized the list of elemental impurities, as well as their PDEs, with the International Conference on Harmonization (ICH) Q3D Step 4 document. In June 2016, the FDA issued guidance on elemental impurities covering ICH Q3D in drug products.
As the deadline for assessing and monitoring elemental impurities approaches, pharmaceutical manufacturers and their service laboratories need to act now or risk not being in compliance with the new regulations. Compliance requires that the analytical methodology be capable of accurately measuring low concentrations of elemental impurities in drug products or its components, as necessary, to ensure patient safety.