This document is out for public consultation. The doucment is comprised of extracts of the Q3D(R2) Guideline with the revisions to the Q3D(R1) Guideline • Part 1 - Extract of Appendix 2: Correction of PDEs for Gold, Silver and Nickel • Part 2 - Extract of Appendix 3: Correction of Gold monograph • Part 3 - Extract of Appendix 3: Correction of Silver monograph • Part 4 - New Appendix 5.
For details, see: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q3d-r2-elemental-impurities-step-2b_en.pdf
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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