Changes are inevitable throughout the lifecycle of a pharmaceutical product, and we know that whether it is to maintain product quality, efficacy or to follow regulatory requirements, these changes bring additional challenges. As such, having a consistent comparability assessment is Read more…
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 Read more…
In one of our latest blog posts we talked about the importance of real-time monitoring to keep Continuous Manufacturing in stable conditions, and we briefly discussed the usage of PAT tools to achieved that. Today, we’ll take a closer look Read more…
Keeping batch records is a matter of compliance. You need to keep (and provide) the entire manufacturing history of every batch that has come out of your facilities. Using an electronic batch record (EBR) system helps streamlining your procedures, boost Read more…
Continuous manufacturing is the future for the Pharma and Biopharma industry. It can bring many benefits to your processes (and ultimately, the business) as it lowers production costs, reduces time to market and improves medicine availability to patients. Despite these Read more…
CSA is an easier and less-resourceful way to validate your computer software. The good news is that if you already use a Digital QRM system you’re one step closer to easily implement CSA. Let’s see! Imagine that you have something Read more…
As you probably already know, the new ICH Q14 guideline proposes science and risk-based approaches for developing and maintaining analytical procedures. To ensure they perform as expected we must have an efficient control strategy. If you want to know how Read more…
Last month, the FDA issued the draft of a new guidance for Computer Software Assurance (CSA) for computers and automated data processing systems. The goal? To describe how can CSA simplify your Validation process. Let’s dive on what is it Read more…
Validation is a process that, for many companies, remains manual despite having high costs, causing errors, and being crowded with inefficiencies. In this blog post we’ll share how to improve your validation process efficiency by moving to digital validation. Read more…
The new ICH Q14 introduces the concept of an enhanced approach for the development of an analytical method. In this approach the analytical procedure is well understood and fit for intended purpose, following a Quality by Design (QbD) approach. However, Read more…