When making parenteral drug products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues (i.e. for biopharmaceuticals) have also become a concern.
This training course will look at Extractables & Leachables from many different angles, including, Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, and Study Design for different parenteral primary packaging systems and injection devices.
A full session will be dedicated to an in-depth update on regulations, standards, and recommendations in this field (PQRI, USP, ISO 10993, BPOG).