The recent changes to the elemental impurities regulation guidelines increase the level of control necessary in testing for heavy metals in pharmaceutical and biotherapeutic products. The use of inductively coupled plasma (ICP) instrumentation is considered the ideal method to determine elemental impurities present in drug products and raw materials. This approach has been proven to be accurate, sensitive, linear, and satisfactory to include in filing reports.
This webinar will discuss:
- An outline of the elemental impurities regulation
- A comprehensive and well-organized way to assess risk
- Examples of techniques used for successful filings
- How agencies are responding now