Substances leached from pharmaceutical manufacturing systems, packages, and/or medical
devices can be administered to a patient during a clinical therapy and can adversely affect …

Substances leached from materials used in pharmaceutical manufacturing systems,
packages, and/or medical devices can be administered to a patient as part of a clinical …

Patients can be exposed to leachables derived from pharmaceutical manufacturing systems,
packages, and/or medical devices during a clinical therapy. These leachables can adversely …

Drug products and medical devices can contain leachable impurities that could adversely
affect patient health during their clinical use. To establish patient exposure to leachables …

Pharmaceutical drug products (DP) can contain foreign impurities due to contact with
manufacturing, storage, distribution and administration systems. These foreign impurities …

A drug product is chromatographically screened for organic leachables, derived from the
product's packaging system, as leachables might adversely impact the health of a patient to …

The issue of extractables and leachables in drugs and packaging is one of the most
complex, challenging, and often (from a regulatory perspective) perplexing in all of …

Demonstrating suitability for intended use is necessary to register packaging,
delivery/administration, or manufacturing systems for pharmaceutical products. During their …

Extractables and leachables are product‐related impurities that result from product contact
with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes …

EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug
products and medical devices Pharmaceutical drug products and medical devices are …