Webinar: Best Practices for the Design & Conduct of Extractables and Leachables Studies based on USP <1663> and <1664>

Over the past two decades, a broad consensus has developed regarding best practices for the design and conduct of extractables/leachables studies related to the variety of pharmaceutical dosage forms.

Download the recorded webinar below. | Original run date: Thursday, March 8, 10:00 a.m. EST

This building consensus was largely initiated by industry consortia, such as the International Pharmaceutical Aerosol Consortium for Regulation and Science, and other industry organizations, such as the Parenteral Drug Association. However, since such organizations have no standard setting or regulatory authority, the United States Pharmacopeia (USP) has developed two informational general chapters which capture these best practices:

  • USP <1663>, which provides guidance on extractables studies.
  • USP <1664>, which provides guidance on leachables studies.

In this 45-minute webinar, Smithers Rapra experts Dr. Daniel Norwood and Dr. Andrew Feilden will provide an overview of both general chapters as well as an overview of the USP process. There will a Q&A period at the end of the presentation. 

 

This webinar is the first in a 3-part series. The mission of the United States Pharmacopeia (USP) is to improve global health through public standards that ensure the quality and safety of medicines. To improve quality standards, USP has developed a series of general chapters to communicate recommendations and expectations surrounding product quality. Join Smithers Rapra experts Dr. Daniel Norwood and Dr. Andrew Feilden for a three-part webinar series providing an overview on selected USP general chapters:

Part 2: Overview of USP Guidance & Standards for Packaging Systems

Thursday, May 3 | 10:00 a.m. EDT | 3:00 p.m. DST

In this 30-minute webinar, Dr. Norwood and Dr. Andrew Feilden will provide an overview on the USP’s recent efforts toward modernizing best practices and standards for pharmaceutical packaging. A variety of material types will be discussed, along with developments in modernizing biocompatibility standards.

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Part 3: Overview of Guidance & Standards for Elemental Impurities (USP <232> and ICH Q3D)

Thursday, June 14* | 10:00 a.m. EDT | 3:00 p.m. DST

In this 30-minute webinar, Dr. Norwood and Dr. Andrew Feilden will discuss the development of new standards for elemental impurities, as formalized in USP <232> and ICH Q3D, along with issues surrounding elemental impurities.

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*Please note the date change: this webinar was rescheduled from Monday, Jue 4 to Thursday, June 14

Meet the Presenters

Dr. Daniel Norwood

Dr. Norwood joined Smithers in 2017 as a Senior Independent Consultant. He has over 41 years of experience in chemistry and pharmaceutical research and is recognized throughout the industry as a pioneer of extractables and leachables science. In addition to extractables and leachables analysis, his areas of expertise include structural analysis of pharmaceutical impurities and degradation products. He has a Doctor of Philosophy in Environmental Chemistry from the University of North Carolina at Chapel Hill.

Dr. Andrew Feilden

Dr. Feilden has over 16 years of experience support the pharmaceutical industry. He joined Smithers Rapra in 2011 and is the Chemistry Operations Director for Extractables and Leachables in the UK, leading a team of experts at two labs in Leatherhead and Shawbury. He has a DPhil from the University of York and is a Chartered scientist and Scientific Advisor to IPAC-RS.