ICH Q3D: Implementation of Guideline for Elemental Impurities
This Implementation Working Group (IWG) was endorsed by the ICH Steering Committee in October 2014. Throughout the development of the Q3D Guideline, external audiences, constituents and interested parties have clearly communicated the complexity of the implementation approaches for this guideline. While the Q11 Guideline provides the framework, it cannot provide the detailed examples covering the breadth of potential case studies for products within scope of the guideline. Consequently, the ICH SC considered that the development of a comprehensive training programme and supporting documentation sponsored by ICH was necessary to ensure the proper interpretation and effective utilisation by industry and regulators alike to enable a harmonised and smooth implementation of Q3D on a global basis.
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