Reviewed in the presentation are three new guidances and how they relate to package/delivery systems:
- ICH Q3D - Elemental Impurities – Guidance for Industry
- USP Chapter <232> Elemental Impurities – Limits
- USP Chapter <233> Elemental Impurities – Procedures.
ICH Q3D applies to new drug products in NA, EU and Japan - considering 24 metals that must be controlled as potential sources of toxicity. A risk-based approach to understanding and controlling these impurities is presented – with emphasis on permissible exposure levels and potential sources (e.g., raw materials, excipients, manufacturing equipment and package/delivery systems). USP Chapters <232> and <233> will replace <231> (Heavy Metals) as of 1-Jan-2018. In line with ICH Q3D, Chapters <232> and <233> discuss not only permissible exposure levels of 24 metals, but analytical methods for detecting and measuring them. Combined, these guidances provide a comprehensive strategy to understand, control, and measure metal impurities in finished drug products. It is imperative for a manufacturer of package delivery/systems to know the regulatory landscape and how regulations interact. West has this knowledge and can couple it with extensive analytical capabilities to support customers in their development efforts.