When we discuss Quality Risk Management, we often focus on the operation, shop floor side of the processes. Today we’ll talk about some of the key aspects of QRM for the top-tiers of the Pharmaceutical Companies and how bringing the digital transformation to Global QRM can have a major impact. Read more…
The success of a globalisation strategy relies on a key pillar: process and product performance comparability. This is so because global pharma companies require flexibility to produce the same product across a network of manufacturing sites and locations. For this blog post, we’re going to offer our perspective on how to handle 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…
The new ICH Q13 guideline is almost here! The guideline on continuous manufacturing (CM) is currently under public consultation and the general deadline for comments is end of 2021. We, as 4TE, have been actively involved on the public consultation phase. And, because of that, we thought of talking a Read more…
In our recent blog post we talked about the benefits and challenges of Continuous Process Verification (CPV) Implementation. We hope you’re convinced! This time we want to talk about how to do a CPV Implementation. CPV implementation requires that, first, you use a well thought logic and rationale that we Read more…
Tech Transfers, or Technology Transfers, usually imply that you’re moving the manufacture of a drug from one facility, one scale or one drug lifecycle phase to another. Which is why they are so important. When you switch facilities, you want to transfer the knowledge and reproduce the process smoothly. The Read more…
Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts in biologic development. These concepts are helpful to compare biosimilar and reference products. But they can go beyond Read more…
One of the goals of industry 4.0 is to achieve end-to-end digital process integration. In this post we’ll talk about the KASA Initiative and how it enables knowledge. And then, how that knowledge supports process monitoring, control and understanding. This can be achieved through a complete data knowledge dimension, from Read more…
When we look at the future, as 4TE, we believe there is an area that gets more important by the day: Building Custom-made Platform for Pharma. To do this in an Agile way, it implies that we develop prototypes swiftly for these digital solution projects. We do that in R. Read more…
Changes are challenging, and in the digital world what we see the most are changes due to the continuous development of new technologies and concepts. Let’s look back at the Computer System Validation (CSV) history. Back in the 90’s, the FDA started to increase their expectations regarding computer system compliance Read more…