WHO publishes revised Draft Guideline on Quality Risk Management

In our GMP News from 23 September 2010, we referred to a draft guideline of the WHO on quality risk management (QRM). Now, this draft has been revised and published for comment.

The new document contains 27 pages and is slightly more extensive than the previous draft which had 24 pages. The current draft is divided into 7 chapters containing diverse subchapters:


1.1 Background and scope
1.2 Principles of quality risk management


2.1 Initiating a QRM process
2.2 Personnel involved in QRM
2.3 Knowledge of the product and process
2.4 Risk assessment
2.5 Risk control
2.6 Risk review
2.7 Verification of QRM process and methodologies
2.8 Risk communication and documentation


3.1 Training and education
3.2 Responsibilities
3.3 QRM application during product development
3.4 QRM application during validation and qualification
3.5 QRM application during commercial manufacturing
3.5.1 QRM integration with key quality system elements
3.5.2 QRM application in product manufacturing operations


4.1 Introduction
4.2 QRM application to inspection strategy
4.2.1 Risk management in inspections
4.2.2 Inspection planning and conduct
4.2.3 Corrective action and preventive action review, and scheduling of routine inspections
4.2.4 Complaint handling and investigation
4.3 Inspection of QRM at a manufacturing site
4.3.1 Inspection of the QRM methodologies
4.3.2 Inspection of individual risk-based decisions
4.4 QRM applied to dossier review (assessment)




The document is largely based on the ICH Q9 guideline and uses its common terminology. Unlike ICH Q9 which contains just over 10 pages without annexes, the draft presents detailed explanations as well as detailed provisions. For example, at least one "Risk Review" should be signed by the quality assurance unit. Verification of the QRM processes and specific QRM applications should be performed by a third party. Chapter 5 (Risk Management Tools) refers to tools which are also described in Annex I of ICH Q9. In addition, a risk matrix in a tabular form describes examples and risk management tools (methods, description of the methods, potential applications) A publication of the "Manufacturing Technology Committee" from the "Pharmaceutical Quality Research Institute" (PQRI-MTC) dated from 2008 is explicitly quoted for the examples presented.

The European Compliance Academy has commented a few parts of the document:

The ECA basically recommends a flowchart to be able to perform the risk-based analysis of a process. In the draft, the use of a flowchart is described as "if needed" and not really binding ("may use").

Besides, the ECA discovered inconsistencies with regard to responsibilities. For example, the signature of the quality assurance unit is required for "Risk Review" but the responsibility is not mentioned in the respective chapter 3.2.

Regarding the use of QRM for qualification activities (chapter 3.4), the document concedes that often only IQ, OQ, PQ are being performed. In this context, the ECA points out - with high priority - that DQ plays a decisive role in the qualification life cycle and should be therefore integrated in the QRM process - except for the qualification of older facilities.

Conclusion: It is up to the WHO to decide whether and how the comments of the ECA (and further organisations) will be taken into account. Of course, we will keep you informed about the publication of the final version in one of our next GMP News.

Comments to the WHO's draft "WHO Guideline on Quality Risk Management" can be sent until the end of October 2012. If you wish to give a comment, you can find a "comment template" on the WHO's website.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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