Drug shortages have been a growing worldwide issue in recent years and represent a significant negative impact on patients’ lives. As we saw during COVID-19 and now, with Russia-Ukraine war, pharmaceutical manufacturing and distribution are facing many challenges. However, the risk of unavailability or limited supply of a drug can be Read more…
Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains. One example that is Read more…
The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us to this blog post: why a Digital QRM System for 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…
In this article we will discuss the ever growing importance of Quality Risk Management in the context of Lifecycle Management. Risk and knowledge management were introduced by the ICH guidelines (ICH Q8 onwards). Since then, they became increasingly appreciated and implemented through other guidance such as the EU-GMP Guidelines. The forthcoming ICH Read more…