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…
By now, most Life Sciences Companies have made significant investments in the digitisation of their processes to get the most out of the benefits of Digital Transformation. This digitisation is nothing more than the conversion of documentation and materials so they can be processed by computers. For that purpose, numerous Read more…
There is no single method that is solely decisive for a conclusion on biosimilarity of acertain candidate. But we can talk about streamlining the demonstration on biosimilarity. Demonstrating Biosimilarity According to the FDA, the approval of a biosimilar should be based on the integration of different information using a totality-of-evidence Read more…
An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by a regulator. Luckily, through a combination of good practices for Benefit-Risk Assessment and technology, this has become much easier. Let’s see how! A matter of benefit-risk Read more…
The acquisition introduces new product synergy across all stages of the validation lifecycle program. San Francisco, June 14th, 2022: ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in manufacturing sciences and technologies (MS&T) that enable the world’s most successful 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…
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…