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Training Modules on "ICH Q3D - Elemental Impurities" published by ICH

The ICH has published the long-announced training modules on the ICH Q3D Guideline "Elemental Impurities". The background for the development of the training modules on "Elemental Impurities" is the complexity of the requirements laid down in the Q3D Guideline. The modules include the following topics from the Q3D Guideline:

The guidances have been categorized under 15 different themes. Out of 15 three documents have been listed under the category of “Pharmaceutical Quality /Manufacturing Standards (CGMP)".as listed below:


• Module 0: Overview of modules 1 to 9
• Module 1: Developing acceptable levels for other routes of administration
• Module 2: Justification for exceeding a Permitted Daily Exposure (PDE)
• Module 3: Developing acceptable levels for elemental impurities not covered by ICH Q3D
• Module 4: Considerations for large volume parenterals
• Module 5: General approaches to risk assessment
• Module 6: Controls on elemental impurities
• Module 7: Calculations between PDE values and concentration limit


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