IGMPI India

Recently ICH announced the establishment of working group whose responsibility would be to elaborate training materials on the Guideline ICH Q3D “Elemental Impurities”. Necessity of the working group has been justified by ICH so as to provide support with regard to implementation of ICH Q3D in the form of training materials based on the experience made with the Q8, Q9, Q10 and Q11 guidelines.

 Due to different interpretations within and outside the ICH regions after the publication of the above mentioned guidelines "Implementation Working Groups" have been established which elaborated training materials to provide support for the implementation of these guidelines. Based on these experiences of different interpretations of the above mentioned guidelines ICH have announced the establishment of working group on ICH Q3D in order to avoid the possible doubts and different interpretation of the requirements of ICH Q3D and provide the training materials in time. The wording in the Business Plan and the Concept Paper suggest the availability of these materials following the publication of ICH Q3D (Step 4) which has been already adopted and is supposed to replace the Draft Consensus Guideline ICH Q3D (Step 2b).

The agenda of the ICH Q3D IWG include the following activities:

• Elaboration of training presentations including:
  
  1 General overview of the guideline and examples of the execution of risk assessments
  2 Examples of application of the guideline to less than daily dosing
  3 Examples of application of the guideline to other routes of administration
• 4 Development of a Questions & Answers document with frequently asked questions (FAQ)
• 5 Creation of a document providing an approach to documenting the information/data supporting the risk assessment to be presented in a regulatory submission
• 6 Supplying the training materials with expert support for workshops and/or web-based sessions