Requirements from regulatory agencies have become increasingly rigorous with regards to the detection, identification, and quantitation of extractable and leachable compounds in pharmaceuticals, drug delivery systems, and biomedical devices. This heightened scrutiny is the result of several well‐documented incidents of contaminants leaching from containers and packaging, causing potential or real risk to humans. Therefore, regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), have increased regulations on potential extractables and leachables in drug product container and closure systems.
Until recently, the primary focus of these studies has been components in direct contact with the drug product for extended periods, such as the primary packaging or those that contact the formulation during administration known as in‐use componentry. However, the components used in manufacturing are of increasing interest as sources of potential leachables. In addition, the rising popularity in biologics and the relative complexity of their manufacture warrants a comprehensive framework for determining the risk of drug product material interaction and systematic approach to addressing these materials with respect to potential leachables.
In this webinar we will review the history of extractables and leachables, discuss best practices with current industry guidelines, and provide a brief overview of developing guidelines.
Extractables & Leachables 101: The Past, Present, and Future is the first in a webinar series where Alcami will discuss extractables and leachables in depth.