Shifting to 4.0 in Life Sciences Production

The Fleming team sat down with Samer Jalal, Hikma Pharmaceuticals, Jordan Operations Excellence Director - MENA regionSteffen Eich, University of St. Gallen, Switzerland Operational Excellence Associate,  Ian Ramsay, UK Former GMP Inspector MHRA , Philippe Lenglet, Servier, France Global IT - Chief Quality Officer,  Ferenc Lukács, Egis Pharmaceuticals PLC, Hungary Associate Director, Quality Management  to discuss:



Where do you see the progress and gaps in embracing 4.0 in Life Science production? What are the main challenges on your transformation journey?




Samer Jalal
Operations Excellence Director - MENA region

Hikma Pharmaceuticals, Jordan

In production, I think we are still at the beginning of the journey; there are several piloting projects for digital transformation in several areas in production, yet we still haven’t reached a completely digitalized production with integrated systems along with common data analytics and AI. The puzzle pieces are joining together slowly and it’s all about finding the right value proposition that can improve the organizational competitiveness in production and supply chain.

The main challenges in the transformation journey are the availability of qualified and committed employees in addition to sufficient financial resources, and by employees I also include leaders/managers. Management needs to be able to spot the right digital project and embrace the digital change.

Briefly, developing the right employee competencies and expertise is the biggest challenge.


Steffen Eich
Operational Excellence Associate

University of St. Gallen, Switzerland


While some companies show astounding progresses in implementing 4.0 solutions, like using augmented reality to cut down set-up times and training efforts, others are struggling. Challenges often are capacity and budget to get projects started, having the right focus and the courage to challenge proven processes.


Ian Ramsay
Former GMP Inspector MHRA, UK


It is an exciting time with newer and newer applications of “big data,” machine learning and true AI. I believe the key challenges for the GMP/GDP world will be translating existing regulations and responsibilities to ever more complex and autonomous systems. This is particularly challenging wherever a critical decision is to be taken – especially where it is a legally prescribed or regulatory decision (e.g., certification, recalls, ADEs, etc.)


Philippe Lenglet

Global IT - Chief Quality Officer

Servier, France


Strategy, not technology, drives digital transformation and innovation to connect people, tools and machines; and help our teams meet customer demands at the right price, at the right time and at the right quality level.


Ferenc Lukács

Associate Director, Quality Management

Egis Pharmaceuticals PLC, Hungary


We at EGIS started to move in the direction of automation in some plant. We have already API plants,. It is a huge challenge since we need different culture in work. difficulties the change the mind of the workers and so on …