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…
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…