The industry of medical cannabis keeps growing. And we’re at the point where legislation is starting to catch up with. In fact, we expect GMP compliance and certification to become standard, just like the other pharmaceutical sectors. That leaves us with one key point to address: risk management. Managing the Read more…
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 Read more…
Subjectivity in Risk Assessments and Quality Risk Management (QRM) outputs has been under the spotlight recently. In this post we will explore why, how, and what are the tools that you can use to minimize it. Current regulatory context Since the publication of ICH Q9 in 2005, it became the Read more…
In this blogpost, we want to make you think about the application of the Quality By Design for Cell & Gene Therapies. Over the past century, lifecycle management of biotechnology products and biopharmaceutical industry has been founded on principles from the pharmaceutical small-molecule industry. But are they suitable for it? Read more…
This is a happy story about Risk Management and Process Optimisation. But it’s also confidential in some parts, which is why we changed names and locations. But don’t worry, we didn’t change any details. A Bottleneck in the Process Our story starts somewhere in central Europe. Our main character is Read more…
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 Read more…