PDA EU00175 Extractables and Leachables for Parenteral Applications Series

When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements 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 become an additional concern.

This education series (pre-recorded webinars combined with live discussions at the end of each day) will look at Extractables and Leachables (E/L) from many different angles:

• Regulatory Requirements and Guidelines
• Materials and Polymer Science
• Mechanisms of Leaching and Material-Drug Product Interaction
• Analytical E/L Methodologies
• E/L Study Design for Different Packaging Systems
• Large Volume Parenterals
• Lyophilization Applications

Several interesting case studies on the above topics will also be presented.

At the end of each day, trainers are available to answer questions in a Live Q&A session.

Upon completion of this training course, you will be able to:

• Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
• Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
• Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
• Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
• Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study