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Risk Management Digitalisation

Development of Quality by Design Frameworks

How to align Analytical QbD with the new ICH Q14?

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…

By 4TE Team, 4 monthsOctober 18, 2022 ago
Quality Risk Management Digitalisation

Practical Suggestions for ICH Q14 Implementation

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…

By 4TE Team, 5 monthsSeptember 19, 2022 ago
Quality Risk Management Digitalisation

GMP Annex 1 Revision + QRM Digitalisation: a perfect match

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 4TE Team, 5 monthsSeptember 5, 2022 ago
Development of Quality by Design Frameworks

New ICH Q14 Guideline: key implementation aspects

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…

By 4TE Team, 7 monthsJuly 21, 2022 ago
Risk Management Digitalisation

Digital Transformation: Impacting Global QRM

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…

By 4TE Team, 9 monthsMay 18, 2022 ago
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4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.




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