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8 Aug 2013

Rx-360 Summary of ICHQ3D, Guideline for Elemental Impurities; Step 2b

ICH posted the 79-page, step 2b version of ICHQ3D, Guideline for Elemental Impurities, on its website on 5 August 2013. The regulatory authorities in the ICH regions of US, Japan and the EU have not yet published it for consultation. The Concept Paper and the Final Business Plan from 2009 are also included here. 

The scope of the guideline includes chemically synthesised drugs, proteins and polypeptides made using cell culture expression systems and resulting conjugated proteins/polypeptides. Elemental impurities in drug product may come from a variety of sources including those added during chemical synthesis, the presence of elemental impurities in raw materials, or those that result from contact with processing equipment. This guideline identifies elemental impurities that may have potential health/toxicology impact, establishes Permitted Daily Exposure (PDE) of those impurities and addresses controls necessary to maintain the impurities below the recommended PDE.  The document includes 7 sections (not including the Introduction and Scope) and four appendices as follows:

◾Safety Assessment of Potential Elemental Impurities (pages 2-4)
◾Element Classification (page 4
◾Assessment and Control of Elemental impurities (pages 5-13)
◾Speciation (page 14)
◾Analytical Procedures (page 14)
◾Life-Cycle Management of the Control Strategy for Elemental Impurities (page 14)
◾Recommendations for Submission of Elemental Impurities Control Strategy (page 14)
◾Appendix 1:   Method for Establishing Exposure Limits (pages 20-22)
◾Appendix 2:  Established PDEs for Elemental Impurities (pages 23-25)
◾Appendix 3:  Individual Safety Assessments (pages 25-69)
◾Appendix 4:  Illustrative Example — Calculation Options for Converting PDEs to Concentrations (pages 69-79)

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