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 to do, your brain is going to rapidly process how 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, how can companies connect already existing Analytical QbD (AQbD) and Read more…
The new ICH Q14 guideline arrived to harmonise scientific approaches of Analytical Procedure Development. And this raises the question: how will we implement it? Luckily, we recently had an enlightening talk with Jean-François Dierick and Claudia Magagnoli about how they did it at GSK. Flexibility is the word The enhanced Read more…
The European Union has released the new (and very much anticipated) GMP Annex 1 revision after 14 years of development! The GMP Annex 1 has all the manufacturing requirements sterile drugs both made in the EU and imported products. This 2022 version presents an upgrade to 59 pages from the Read more…
The International Council for Harmonisation (ICH) released a draft of the new ICH Q14 Guideline last March. This is the first guideline on analytical procedure development and it’s generating a lot of interest since it can help achieve more robust analytical processes. Along with the revised ICH Q2(R2) Guideline on Validation 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…
Making Post-Approval Changes can be a challenge. You have different timelines, different submission requirements and trouble optimising your processes. Because of that, this makes the knowledge of creating a post-approval change management (PACM) protocol all the more important. And that’s what this blog post is all about! In it, we’ll 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…
With a new guidance on Data Integrity (DI) being prepared by the World Health Organization (WHO) to replace its previous one, this is a good time to look at Data Integrity in Healthcare! On that note, keep in mind that regulatory agencies also have their own guidelines: European Medicines Agency Read more…
The Cell and Gene Therapies industry is growing at a tremendous speed, building both on innovative solutions and a solid investment by life science companies who wish to diversify their market offer. The results have been impressive and Patients who had exhausted treatment options are getting exciting new opportunities. To Read more…