How One Might Experimentally Determine if Container Closure Systems and Their Components and Materials of Construction Contribute Elemental Impurities To Packaged Pharmaceutical Drug Products

Abstract

The safety aspects of elemental impurities in finished drug products are a topic of considerable importance in the pharmaceutical community, and guidelines such as ICH Q3D and USP <232> and <233> have been published to provide directions on how to assess finished drug products with respect to such impurities. Although a drug product's packaging system has been identified as a potential source of elemental impurities, comparable guidelines have not been established for assessing packaging systems and their materials and components of construction with respect to their potential to contribute leached elements to packaged drug products. In this commentary, the author considers the critical questions associated with selecting materials and components of construction and qualifying components and packaging with respect to their potential to add elemental impurities to packaged products and suggests means for accomplishing this objective.

LAY ABSTRACT: Elemental impurities in drug products can adversely affect the drug product's quality attributes. Regulatory guidelines that establish how to assess drug products for elemental impurities have been published. Although the drug product's packaging system has been identified as a potential source of elemental impurities, no guidelines have been published to specifically address packaging. In this commentary, the author considers the key issues associated with elemental impurities derived from packaging and suggests means for selecting and qualifying packaging on the basis of extractable elements.