Extractables and Leachables: Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Devices

Learn to address the safety aspects of packaged drug products and medical devices

Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these ...