It has been 15 years since ICH Q9 came to light and a revision is finally arriving.

The year was 2005 when the European Medicine Agency published the ICH guideline Q9 on Quality Risk Management. It was a big step forward at the time for a few reasons:

  • There was no shared understanding of the application of risk management
  • Manufacturing a medicine implies, by nature, a level of risk
  • It facilitated better and more informed decisions
  • It provided regulators with greater assurance of a company’s ability to deal with potential risks

Long story short: it was a success! This guideline quickly became the state-of-the-art for quality risk management (QRM) in the GMP environment. 

How? It provided principles and examples of tools for quality risk management that can be applied to several aspects of pharmaceutical quality.

Why do we need to review ICH Q9?

Let’s be clear: the current guideline has been great at bringing QRM principles to both industry and regulators. However, there was a vision of its benefits, and it hasn’t yet been fulfilled. What are they, you ask? There are four areas of improvement within the current application of QRM:

  • High levels of subjectivity in risk assessments and in QRM outputs. While subjectivity cannot be eliminated from risk assessment and QRM activities, it may be controlled using well recognised strategies, including addressing bias and behavioural factors.
  • Product availability risks. ICH Q9 is not a supply chain guideline, but quality and manufacturing issues that impact the supply chain and product availability can create risks to patients, and management of these risks is important.
  • Lack of understanding as to what constitutes formality in QRM work. There has been some confusion and uncertainty in the industry and among regulators as to what constitutes formality in QRM work, and how generally to interpret this principle.
  • Lack of clarity on risk-based decision-making. There is lack of clarity on what good risk-based decision making actually means, how QRM may improve decision-making, or how risk-based decisions might be achieved.

So, what is the plan?

There are two main deliverables:

  1. A revised ICH Q9 Guideline featuring targeted revisions to specific chapters and annexes to the four areas we mentioned.
  2. Specific, officially accessible, ICH training materials (with examples) beyond the “briefing pack” on ICH Q9 which is already available.

Additionally, there are two other aspects that can benefit from the revision of the guideline:

  • Digitisation (e.g., new manufacturing technologies, automation, and use of big data). As digitisation is implemented in the industry, applying QRM to the design and validation of processes, technology transfer, and the introduction, validation, and use of computerized systems will take a bigger role.
  • Emerging technologies. Emerging technologies (like continuous manufacturing or process analytical technologies (PAT)) will also benefit from further use of science based QRM activities.

What are the expected benefits?

This revision will produce a very set of benefits for the Pharmaceutical industry.

First, we’re expecting more scientific and robust applications of QRM principles, tools, and activities, where
subjectivity in QRM outputs is better controlled. This will mean fewer quality defects and recalls for patients, and potentially in reduced costs for the pharmaceutical industry and healthcare systems.

Secondly, it will increase competencies in how risks, hazards, and harms are identified, assessed, perceived,
and communicated.

This means a more efficient use of QRM resources – we will deal with lower risk issues via less formal means, freeing up resources for managing higher risk issues.

The revision will also improve the decision-making on risk issues across a multitude of areas and activities relevant
to both regulators and the pharmaceutical industry.

Finally, it establishes the standard for a more robust application of QRM using analytics as digitisation, automation, and recent technologies are implemented in manufacturing facilities.

Who is the ICH Q9 review for and when should it be expected?

Short answer: everyone! But, if you want to get specific, these benefits are for:

  • Branded and Generic Drug Manufacturers
  • Biological and Small Molecule Manufactures
  • Marketing Authorisation Holders
  • Wholesalers
  • Contract Research Organisation
  • Assessors
  • GxP Inspectors
  • Testing Laboratories
  • Many others!

By now, you are probably asking what the milestones are you should be paying attention to. It’s a great question! These are the dates you should pay attention to:

  1. Final Concept Paper and Business Plan endorsed: November 2020
  2. Adoption of the draft guideline: November – December 2021
  3. Regulatory Consultation: January – March 2022
  4. Development of Training Materials: October 2021 – August 2022
  5. Finalisation and Work Group endorsement of the ICH training materials: August 2022
  6. Adoption of final ICH Guideline: September 2022

Is your QRM Process causing difficulties?

4TE has solid expertise with Quality Risk Management Optimisation and we deliver it through our consulting and one of the best QRM platforms in the market.

We recommend that you check our QRM Process Optimisation Services. If you think we may be able to help you out, don’t hesitate to book a call, we’ll do our absolute best to help.

Related topics

If QRM is a topic of interest to you, we recommend you checkout this article of ours: QRM over Lifecycle Management.


We wrote this article using the following references:

  1. ICH Q9 – Quality Risk Management Final Concept Paper
  2. ICH Q9 – Quality Risk Management Business Plan