New: ICH Guideline for ICH Q8, Q9 and Q10 implementation

On 16 June 2011 the International Conference on Harmonisation (ICH) Quality Implementation Working Group published a new document entitled: "POINTS TO CONSIDER ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation".

The new document is based on questions that have been raised during the workshop sessions organised by ICH in the three regions (Europe, US, Japan). The Guide is intended to provide further information on the implementation of ICH Q8/Q9/Q10 for both industry and regulators.

There is still a lot of uncertainty about how the three guidelines should be used in combination. According to the stakeholders, regulatory flexibility might be one essential benefit for the implementation of the three guidelines. However, the concrete consequences about how to achieve these benefits are not clear yet. Moreover, different regional requirements increase the complexity of the implementation.

The new Points to Consider Guide is structured in 3 main elements:

  • CRITICALITY OF QUALITY ATTRIBUTES AND PROCESS PARAMETERS
  • CONTROL STRATEGY
  • LEVEL OF DOCUMENTATION IN ENHANCED (QbD) REGULATORY SUBMISSIONS

In Section 2 some clarification is given about the relationship between Critical Quality Attributes (CQAs), Critical Process Parameters (CCPs) and the Quality Target Product Profile (QTPP). Section 3 contains information about the relevant aspects of a Control Strategy (e.g. development, change management). Some clarification is also given with regard to the purpose of specifications and Certificate of Analysis (CoA) for Real-Time Release Testing (e.g. not all CQAs need to be included in the specification). Finally Section 4 deals with the level of documentation required in QbD submissions. The document recommends that QbD submissions should have a statement by the applicant describing the proposed regulatory outcome and expectations. Furthermore the QbD application should address the following information:

  • The scientific justification of the proposed Control Strategy.
  • The scientific rationale for the studies conducted.
  • A concise description of methodologies used to conduct these studies and to analyze the generated data.
  • The summary of results and conclusions drawn from these studies.

Two ECA events will cover the implementation process topic. ICH Q9 and ICH Q10 will be the focus of a Training Course with practical examples in Budapest from 19-21 October.

The implementation of QbD in accordance to ICH Q8 as well as the impact of the new FDA Process Validation Guide will be covered in workshops and case studies at the QbD/PAT Conference in Heidelberg from 5-7 October.

Author: Oliver Schmidt, Concept Heidelberg (a service provider entrusted by ECA)

Source: ICH Website

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