Applications – Pharmaceutical Drug Products – Packaging

Abstract

Pharmaceutical drug products and medical devices are packaged to ensure their integrity and stability during post-production shipping and storage prior to clinical use. As packaging directly or indirectly contacts the drug product or medical device during shipping and storage, the packaging and packaged item can interact via transfer of chemicals. Leaching is the process of transferring chemicals from the packaging to the packaged items and leachables are thus foreign impurities in the packaged item. As such, leachables can affect the packaged item's quality and safe use properties. This chapter summarizes the regulatory and scientific landscape for leachables, leachables testing and leachables impact assessment. Regulatory guidelines, compendial monographs, and interest group best practice recommendations are identified and discussed in detail. A means of classifying drug product types in terms of leachables risks is established and a risk-based testing paradigm is discussed. Case studies involving leachables testing and evaluation are provided.