ICH Working Group Elaborates Training Materials on ICH Q3D

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

The ICH has recently announced in a Business Plan and a Final Concept Paper the establishment of a working group whose task will be to elaborate training materials on the Guideline ICH Q3D "Elemental Impurities". The ICH justifies the necessity of providing support with regard to the implementation of ICH Q3D in the form of training materials based on the experience made with the Q8, Q9, Q10 and Q11 guidelines. After the publication of those guidelines, it has come to various interpretations within and outside the ICH regions despite clear linguistic and unambiguously formulated text in these guidelines. After that, IWGs ("Implementation Working Groups") have been established which elaborated training materials to provide support for the implementation of these guidelines.

Based on these experiences, the ICH now wants to avoid if possible the ambiguity phase and divergent 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 that the availability of those materials shall follow the publication of ICH Q3D (Step 4) in quick succession. This means that the publication of ICH Q3D (Step 4), which has already been adopted and is supposed to replace the Draft Consensus Guideline ICH Q3D (Step 2b) will probably still take some time!

The timing described in both the Concept Paper and the Business Plan includes the following milestones:

• Agreement of Concept Paper and Business Plan by the Q3D EWG: 3 October 2014
• Adoption of Concept Paper and Business Plan by the ICH Steering Committee: 21 October 2014
• Establishment of the ICH Q3D IWG: 31 October 2014
• IWG meeting to finalize training materials: 1st quarter of 2015
• Training materials finalised: 31 March 2015

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

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

Hereof, the ICH expects a large elimination of ambiguities and a harmonised implementation of the requirements laid down in the guideline.