ICH Q9 on Quality Risk Management Now Available

GMP News No. 647

GMP News
8 December 2005

ICH Q9 on Quality RiskManagement Now Available

In our GMPNews of 6 April 2005 we informed you that the ICH Guideline Q9"Quality Risk Management" had been finalised. At that time, theguideline was not available yet. Now, the ICH published the new text onits website for download. You will find the respective link at the bottomof this page.

This document has now passed step 4 of the ICH process and is thusready 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 depictingthe risk management process (chapter 4). Compared to the former flowchart(see illustration 1), risk communication has been isolated from thisprocess to form a process step of its own running parallel to the process(see illustration 2). The step "Output/Results of the Risk ManagementProcess" remained in the process. The step "Risk Review"has also been modified, namely by removing the sub-step "RiskAcceptance". However, the "Risk Review" still leads back tothe process, with the difference that it now goes back only as far as theprocess step "Risk Control". The definition of "RiskReview" was adapted accordingly (chapter 7).

Illustration 1 Outdated Quality Risk Management Process according to ICH Q9 (Step2, 22 March 2005)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" inthe sub-chapter "Risk Analysis" of chapter 4 included thestatement that, for some tools, the factor "detectability" waspart of risk assessment. "Detectability" was also mentionedas a factor in other passages (e.g. under "Risk ManagementMethodology", chapter 5).

Despite the changes in the flowchart, the contents of the correspondingdescriptive sub-chapters have not undergone major changes. One smallexception is the addition of monitoring activities within the framework ofthe "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 ManagementMethodology". This chapter also deals with "Informal RiskManagement", which is no longer listed among the tools. The new AnnexI now begins with an introduction that leaves a lot of room forflexibility in the implementation of the tools. As an example, the list oftools is described as "not exhaustive", and the text points outthat none of the methods is suitable for every purpose.

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

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

Some minor changes have also been made to Annex II ("Potential Applications forQuality RiskManagement"). Regarding development, sub-chapter II.3 has a strongerreference to ICH Q8. The term "design space" is mentionedexplicitly. The reference to human errors was omitted.

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

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

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

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

Further changes consist mainly in rephrasings without any consequencesfor the contents.

You can download the ICH Q9 Guideline by clicking here.

Sven Pommeranz
on behalf of ECA

Our seminar recommendation: Learn how to apply ICH Q9 to computervalidation!
The Risk-Based Approach to Computer Validation, Berlin, Germany, 8-9 May2006

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