The new ICH Q14 introduces the concept of an enhanced approach for the development of an analytical method. In this approach the analytical procedure is well understood and fit for intended purpose, following a Quality by Design (QbD) approach.

However, how can companies connect already existing Analytical QbD (AQbD) and align it with the new ICH Q14? In our last 4TE Talk, Jean-François Dierick and Claudia Magagnoli explained us how based on their experience in GSK.

Manage your knowledge 

It’s all about knowledge. The knowledge that you already have and the knowledge you generate.

There might be a perception that QbD is about the systematic use of huge Design of Experiments (DoEs) and a lot of statistics and that it requires a big investment. However, you should only invest in these DoEs if you need to. Thus, if you already have the knowledge required for a specific method, there’s no need to invest in it. Test and invest only when you’re lacking that knowledge.

Therefore, most of the time you already generate and/or manage knowledge, even if you do not strictly apply the enhanced approach proposed in ICH Q14. And you probably already take decisions and manage risks based on that knowledge. What ICH Q14 proposes is to use and generate knowledge with a specific target, which exactly correlates to the concept of “Quality by Design”.

Improve your methods with AQbD and ATP

Applying AQbD allows you to produce better characterised methods that address a pre-defined need. On the other side, the Analytical Target Profile (ATP) is used to define your performance target.

At the end you obtain a well-defined method suited for your needs, but how will you maintain its performance? Afterwards, you apply knowledge and risk management to address this ATP, making sure the method is in control and meets the criteria defined.

After development, the QbD approach also supports in your method monitoring, based on the knowledge acquired at two different stages:

  • Development
  • Validation

Thus, you can monitor these methods over time and over changes. And, ultimately, the knowledge that will be acquired during the lifecycle, if adequately managed, can give you feedback for your next developments. Which means that you can and should perform some changes if you know that certain elements are harmful towards the performance of the method.

Connecting knowledge and risk management

It all comes down to the following connection:  

ATP – Knowledge management – Risk assessment

The ATP can drive the knowledge that you already have. At the same time, this knowledge informs your risk assessment, helping you identify the risks, evaluate, and control them. On the other hand, by performing risk assessments you can easily identify ATP requirements and business drivers, apart from allowing you to score the potential methods against the defined criteria.

Therefore, this is what you gain by generating knowledge: a system that support you in the continuous improvement of your analytical methods.

Accelerate your implementation of the ICH Q14 guideline with Digital QRM

From the ICH Q14 guideline, it’s easy to conclude that risk management plays an important role in the success of the development of an analytical method and its validation.

Implementing a digital Quality Risk Management (QRM) platform can help you define the ATP and select the technology more easily. This way, it allows you to collect the benefits of the enhanced approach faster. Additionally, it can also optimise the risk management over the procedure’s lifecycle and help you determine the required control strategies.

We can support your ICH Q14 implementation

4TE has a lot of experience in QRM and, along with our risk management platform, we can help you define the ATP and facilitate your ICH Q14 implementation.

Additionally, you can benefit from our iSEE Platform™, a robust Data-Science platform that can support you in managing all your data and knowledge, improving your decision-making, and informing your risk management.

If you want to know more about these solutions, we welcome you to check out the iRISK™ and/or the iSEE Platform™ website! And don’t hesitate in reaching out if you’d like to discuss how we can support you.

Interested in ICH Q14?

Do you want to know more about the new ICH Q14? Check our blog post: Practical Suggestions for ICH Q14 Implementation

Or you can watch our 4TE Talk with Jean-François Dierick, Strategic Analytical Validation and Lifecycle Lead at GSK, and Claudia Magagnoli, Leader of the Global Platform for Separations in Analytical R&D at GSK.