Quality Risk Management (QRM) and ICHQ9 – Part 1

Quality Risk Management (QRM) and ICHQ9 – Part 1

The International Conference on Harmonisation (ICH) guideline Q,  Quality Risk Management, is the first internationally recognised guideline that specifically addresses QRM for the pharmaceutical and biopharmaceutical industries. 

Published in June 2005, the guideline offers an overview of the general principles of quality risk management, an example of a risk management lifecycle, a discussion of the activities that occur at each stage of the cycle and a list of tools and areas of the quality control system to which QRM can be applied.

ICH Q9’s intention is to focus the behaviour of industry and regulators on the two primary principles of Quality Risk Management, which are:

  • quality risk assessment should be based on scientific knowledge and related to patient care;
  •  the effort level and documentation of the Quality Risk Management process must be commensurate with the level of risk.

There is no Zero risk

Risk is defined as the combination of the probability of damage occurring and its severity. The ICH Q9 Guideline debunks a myth found in previous industrial and regulatory cultures: the concept of zero risk. In the old quality paradigms, drug manufacturers sought to eliminate risk from their products and processes, taking their cue from regulators who implied, through publications and regulatory inspections, that no degree of risk was acceptable. However, ICH recognises that “the manufacture and use of a drug (medicine), including its components, necessarily involves a degree of risk”, which must be managed to protect product quality and patient safety. The challenge, therefore, shifts from achieving an almost impossible concept of ‘perfect’ quality to understanding what constitutes an acceptable risk and attempting to reach that state.

Moreover, risk management is not necessarily linked to the use of rigorous and detailed tools, such as FMEA, instead the guideline explains how to apply the principles of risk management to the practice of risk management itself; the use of formal or less formal approaches is acceptable, provided that the effort is proportionate to the risk of the product, process or system to be assessed. This enables the industry to incorporate risk management into all aspects of operations without the need to undertake a formal, staff-intensive exercise. 

QRM does not replace regulatory requirements

Furthermore, Q9 is quite clear that “the appropriate use of quality risk management can facilitate but does not remove the industry’s obligation to comply with regulatory requirements and is not a substitute for appropriate dialogue between industry and regulators”. Moreover, compliance with all applicable laws is mandatory; risk management cannot be used to justify non-compliance or to argue why a regulatory requirement need not be met. 

Rather, QRM can be used to offer perspectives on how to best comply with standards and to characterise aspects of quality that are not specifically associated with compliance.

More info: Tools and tips to make the best use of Quality Risk Management 

Advantages of a QRM approach 

  • Improved product quality assurance through proactive identification and avoidance or minimisation of quality risks
  • Identifying sources of variation in the product and production process that can be targeted for continuous improvement;
  • Improved decision making as QRM provides a lens through which scientific data and information can be viewed to better evaluate options and understand the potential outcomes of a given decision; 
  • It has a positive impact on the scope and level of regulatory oversight, increasing confidence in the authorities.


ICH. ICH Q9: Quality Risk Management. June 2005
Quality Risk Management 101: ICH Q9 In Context – Pharmaceutical Online – March 28, 2018

More info: Quality Risk Management Lifecycle – Part 2

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An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes