Regulators expect sound Quality Risk Management in the field of Comparability. And this, despite the fact that the ICH Q5E, the key guideline on comparability, was published before the ICH Q9 on Quality Risk Management.
This blog post will give you some considerations on Quality Risk Management and how it applies to Comparability Studies.
Risk Assessments, are they essential on comparability studies?
The answer is yes!
Risk assessments should not be an option and, of course, you need to consider them in your comparability studies as they undoubtedly add value to the exercise. And, in addition to that, the risk assessments are also clearly expected by all the regulatory agencies.
Yes, we know that your risk assessments will be more complete in the late stages. But consider this: having risks assessments in the early stages is equally important! The difference is always in the amount of information you have at every stage of the process.
And why making risk assessments is important? Well, more than helping you identify which quality attributes you will need for your comparability studies, performing risk assessments will help to define appropriate control strategies.
But how do you make your risk assessments?
It’s fundamental to determine the risk for the patient in terms of impact and uncertainty. The first step is to define the Quality Attributes that are critical to your process – the so called CQA’s. So, if you detected an evident impact on the product quality, you’ve cleared found what is going to be your CQA’s.
Once you define what is going to be your CQA’s, you can work on your risk assessments using methods like FMEA, which gives you an overview of the failure modes associated with your process, as well as the corresponding impact on your product.
And what are the elements you need to consider in your control strategy?
When we talk about control strategy in comparability studies, there are some elements you need to guarantee in order to deliver efficacy and safety at the end of all processes. The elements we’re talking about can be:
- Raw material control.
- Operational parameters.
- Procedural control.
- In-process testing.
- Process validation.
- Lost Release testing.
- Stability testing.
- Characterization testing.
The most important thing is assuring that you will do a comparability assessment in case your process change poses risks to the quality of the product or the safety of the patient. And why? Because doing comparability tests will help you mitigate the risks during the process development!
Would you like to know more about quality risk management in comparability assessments?
This topic was one that Stephan Krause, PhD, talked about in our 4TE talk about Comparability. If you would like to go a little deeper into Quality Risk Management and Comparability Assessments, click here and enjoy the full version.
If this is a topic of interest to you, have a look at our last readings about Comparability Studies. Just click here!