ICH Q9 on Quality Risk Management Now Available

This document has now passed step 4 of the ICH process and is thus ready for implementation in the corresponding 3 ICH regions: EU, USA, Japan.

It is surprising that some new changes were made to the document.

The most conspicuous change has been made to the flowchart depicting the risk management process (chapter 4). Compared to the former flowchart (see illustration 1), risk communication has been isolated from this process to form a process step of its own running parallel to the process (see illustration 2). The step "Output/Results of the Risk Management Process" remained in the process. The step "Risk Review" has also been modified, namely by removing the sub-step "Risk Acceptance". However, the "Risk Review" still leads back to the process, with the difference that it now goes back only as far as the process step "Risk Control". The definition of "Risk Review" was adapted accordingly (chapter 7).

Illustration 1 Outdated Quality Risk Management Process according to ICH Q9 (Step 2, 22 March 2005)

Illustration 2 Current Quality Risk Management Process according to ICH Q9 (Step 4, 9 November 2005)

The description of the "Quality Risk Management Process" in the sub-chapter "Risk Analysis" of chapter 4 included the statement that, for some tools, the factor "detectability" was part of risk assessment. "Detectability" was also mentioned as a factor in other passages (e.g. under "Risk Management Methodology", chapter 5).

Despite the changes in the flowchart, the contents of the corresponding descriptive sub-chapters have not undergone major changes. One small exception is the addition of monitoring activities within the framework of the "Risk Review".

One example for a minor change to the guideline is the fact that the "Risk Management Tools" were moved to an annex (Annex I). Therefore, the title of chapter 5 was changed to "Risk Management Methodology". This chapter also deals with "Informal Risk Management", which is no longer listed among the tools. The new Annex I now begins with an introduction that leaves a lot of room for flexibility in the implementation of the tools. As an example, the list of tools is described as "not exhaustive", and the text points out that none of the methods is suitable for every purpose.

Furthermore, the possible areas of application of FMEA have slightly been extended. The text says that FMEA can also be used for resource deployment. Similarly, HACCP analysis is not considered as limited to the manufacturing process any more.

Even though they were already mentioned in the Step-2 document, terms like "decision maker" and "detectability" have been included into the definitions (chapter 7). The definition of "uncertainty" was omitted. Apart from that, the definitions now also refer to other ICH documents (especially to Q8 and Q6a). As a consequence, ICH Q8 was included in the list of references (chapter 8).

Some minor changes have also been made to Annex II ("Potential Applications for Quality Risk Management"). Regarding development, sub-chapter II.3 has a stronger reference to ICH Q8. The term "design space" is mentioned explicitly. The reference to human errors was omitted.

Under the title "Design facility/equipment" (sup-chapter II.4), two further aspects were included:
"Clean rooms versus isolators" und "Dedicated or segregated facilities / equipment".

The topic storage, logistics and distribution (sub-chapter II.5) has been extended by a paragraph on storage and transport conditions ("cold chain management"). Within the framework of this amendment, references have been made to other ICH guidelines.

Sub-chapter II.6 "Quality Management as Part of Production" was extended by a point on production planning. 

The former sub-chapter "Quality Risk Management as Part of Continuous Improvement" was left out.

Further changes consist mainly in rephrasings without any consequences for the contents.

You can download the ICH Q9 Guideline by clicking here.

Author:
Sven Pommeranz
on behalf of ECA