IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


PQRI/USP schedule elemental impurities workshop

On November 2-3, the Product Quality Research Institute (PQRI) and US Pharmacopeia (USP) will hold a joint workshop on ICH Q3D Elemental Impurities at the USP meeting centre in Rockville, Maryland.

The implementation of the ICH Q3D guideline will go into full effect in the US and Europe in 2018 for all products. The Q3D guideline has been applied to new drug applications in the US and Europe since June 1, 2016.  This workshop will provide an overview of the first 16 months of compliance experience and will review ongoing work throughout industry to resolve challenges involved in global implementation of the elemental impurities (EI) guidelines and standards.

Specific topics will include the following:

  • Update on Recent US/EU/JP Regulatory Guidance, Compendial Chapters and further ICH EI Initiatives
  • Company and regulator experience with implementation for new drug applications since June 2016
  • Implementation of Q3D requirements for OTC and existing Prescription Drugs in January 2018 – Challenges and Expectations
  • Acceptable Risk Assessment Strategies
  • Global Developments for EI Requirements
  • PQRI Phase 2 Collaborative study - outcomes and recommendations
  • Outstanding Analytical Challenges

The workshop will include global experts from ICH Q3D IWG, industry, regulatory authorities, pharmacopeias, and academia who are intimately involved in this area. More information is available here.




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