Elemental impurities in drug products can arise from multiple sources, such as raw materials, excipients, manufacturing equipment and container closure/delivery systems. Risk-based approaches for controlling elemental impurities include specific elements to be considered from any source.

In December 2017 existing drug products in Europe will be required to comply with ICH Q3D Guidelines for Elemental Impurities. Per U.S. Food and Drug Administration (FDA) draft guidance Elemental Impurities in Drug Products, USP <232>/<233> will be applicable to all drug products with USP monographs on January 1, 2018.

Are you ready for the change?

Limits for the various potential elemental impurities are provided in ICH Q3D and USP <232>. In addition to the limits provided, any potential interactions with drug products need to be considered from a product quality and product safety perspective.

Join West experts Diane Paskiet and Diego Zurbriggen on October 19 for a free webinar as they will discuss a comprehensive approach to elemental impurities, including:

    • Potential sources of elemental impurities
    • Toxicity thresholds and other safety considerations
    • Correlations to drug product quality and safety

Ready or not, changes are coming – so join us on October 19 to ensure you’re ready to comply.

Featured Speakers:

Diane Paskiet
Sr. Director, Scientific Affiars
West Pharmaceutical Services, Inc.

Ms. Paskiet has over 20 years of experience in polymer analysis relating to product failures, de-formulation and migration studies. She has served as a project advisor in support of qualification studies associated with packaging and delivery systems for regulatory filings. Prior to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and Expert Committee member. She serves on the Product Quality Research Institute (PQRI) Development Technical Committee and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group.  Ms. Paskiet is also on the faculty of the Parenteral Drug Association Training Institute and is the author/co-author of papers related to pharmaceutical packaging.

Diego Zurbriggen
Supervisor, LeachablesWest Analytical Labs
West Pharmaceutical Services, Inc.

With more than 13 years of laboratory experience, Mr. Zurbriggen brings a wealth of knowledge to his position as Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., in Exton, PA.  Mr. Zurbriggen began work at West in 2003 as a Project Leader in the Raw Materials and Product Testing group, rising quickly to Supervisor of the GxP Support team. As a Senior Chemist, he conducted a variety of analytical investigations supporting internal and external customers, and developed and validated methods using a range of analytical techniques.  In his current role, he supervises a team of eight scientists and serves as the West subject matter expert on elemental impurities. A published author, Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.

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