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 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, Read more…
Cell and Gene Therapy (C>) is a fast-growing field, and that fast growth brings challenges to its development and manufacturing process. Implementing Process Analytical Technology (PAT) and Quality by Design (QbD) might be the answer to overcome some of those 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 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 Read more…
For more than a decade, Digital Twin (DT) technology has gained popularity in many industries. And now it’s time for the pharma industry to also take advantage of the multiple applications of this solution. How? Keep reading to know how Read more…
Who doesn’t like a good story, especially when it has a happy ending? That’s the case of this 4TE story, where we helped a company with their biosimilar product approval. So, fasten your seatbelts and join us in finding out Read more…
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 Read more…
Biosimilars have been experiencing an impressive growth in the last few years. And it’s no wonder because Biosimilars have, on average, a high rate of cost-effectiveness. This is becoming much more important in a world where chronic diseases are more Read more…
Having a CPV Plan brings you a lot of benefits! Benefits that include real-time monitoring of your products’ quality, an effective and consistent control strategy and signalling the discovery opportunities for process improvement. You’d think that everyone would have implemented Read more…