Risk assessments in the Quality by Design Process

There is no doubt if you are working in the pharmaceutical industry you should be employing the Quality by Design principles to achieve robust processes and consistently high quality products. Successful risk assessment is a fundamental aspect of QbD, however, risk analysis is a subjective process and is open to human bias and inaccuracy.

A poorly conducted risk assessment has the potential to hide potential problems, limit understanding and lead to poor justification of unit operations and manufacturing processes.

We have encountered several poor examples of quality risk assessment which normally results in focussing on one key step but not every unit operation in the process. QRA can be a time-consuming process in itself but each step should be investigated to prevent losses later in the development process. Every step in the process including the work up is considered and the process is considered as it would be carried out in the plant, i.e. looking at scale effects. By doing this, you’ll know how to detect changes or identify problems and know the consequences of something going wrong, and therefore how to fix it.

So how can we lessen the risk of the actual risk assessment process? If it is subjective and prone to error, are there ways of carrying out a more robust risk assessment? The results from one risk analyst are unlikely to be obtained by others starting with the same information and therefore using an experienced and multidisciplinary team to conduct the risk assessment is important rather than just having 1 person assigned to the task.

On the other hand, the subjectivity of a risk assessment can also be beneficial as it requires thinking about the problem and process thoroughly in order to avoid bias. Asking the right questions and using the right tools can help deliver a strong risk assessment which can drive development work to produce a robust process. A good risk assessment will: consider all steps in the process, consider specifications for all materials, consider how much and when, consider the appropriateness of IPCs and PAT, consider scale dependent factors and effects and consider equipment.

In January 2020 we did a webinar on QbD and risk assessment. The webinar introduced the QbD process and the FDA’s objective with QbD, focussing on risk assessment with a discussion on different risk assessment tools and a case study. If you’d like to expand you QbD knowledge even more, we have a QbD courses we run online or get in touch for more information.