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Webinar

Do’s and Don’t in setting up Extractables and Leachable Studies, taking into account Existing Standards Guidelines and Recommendations

1 h 19 min

During the production, storage, distribution, and administration of small volume parenteral (SVP) drug products, chemicals can leach from their manufacturing, packaging, and delivery systems. These foreign impurities, known as leachables, can significantly impact the quality of SVPs and affect the efficiency of their production. To understand the effects of these impurities, drug products are profiled for leachables, and the related systems are tested for extractables, which are potential leachables.

This presentation at the 2022 Nelson Labs Virtual Symposium will introduce the scientific and practical aspects and principles of the chemical characterization of SVPs and their related systems. Attendees will gain a comprehensive understanding of the methodologies used to profile leachables and test for extractables, ensuring the safety and efficacy of SVP drug products.

The session will include a review of the relevant regulatory guidance, standards, and best practice recommendations. This will help participants navigate the complex regulatory landscape and ensure their E&L studies are compliant with current standards. The presentation will provide suggested best practices, including dos and don’ts, for the design, implementation, interpretation, and submission of E&L studies.

Participants will learn about the critical factors that influence the chemical characterization process, from initial study design to data interpretation and regulatory submission. The presentation aims to equip professionals with the knowledge needed to effectively manage E&L studies, ensuring the quality and safety of SVP drug products.

This webinar is essential for professionals involved in the development, manufacturing, and regulatory compliance of SVP drug products. By attending, participants will gain valuable insights into the best practices for chemical characterization, helping to ensure their products meet the highest standards of quality and regulatory compliance.

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