Articles, Industry 4.0

What is Pharma 4.0? – Insights into the paradigm shift: Written by Christian Woelbeling, Chairman ISPE Special Interest Group “Pharma 4.0”

What is Pharma 4.0?

From Industrie 4.0 to Pharma 4.0. The ISPE initiative driven by the Special Interest Group “Pharma 4.0” created the Pharma 4.0 Operating Model for the Factories and the Supply Chains of the Future. Pharma 4.0 is fueled by e.g. the processing of big data, interconnectivity, collaborative robotics, artificial intelligence and distributed cloud service-based architectures. Digitalization enables the change across the organization and along the complete value chain network. The formula “Industrie 4.0 + ICH Guidelines = Pharma 4.0 Operating Model” is calculated in this ISPE Special Interest Group and it adds additional Enablers and Elements to the ICH Q10 Pharmaceutical Quality System which are based on the defined Companies Structural Areas of the acatech Industry 4.0 Study.  The Pharma 4.0 Operating Model (Picture 1) is the pharma specific interpretation of the Industrie 4.0 capabilities across the functional areas of the business: Resources, Information Systems, Culture and Organization & Processes. ICH is the regulatory standard for this Pharma 4.0 Operating Model. The concept of the ICH based Control Strategy is the basis for the holistic approach of enabling “lab to patient” or even “patient to patient” value chains for the Next Generation Therapies controlled by the ICH Q10 Pharmaceutical Quality System/PQS.

PHARMA 4.0 Operating Model (Source: ISPE SIG “Pharma 4.0”)

In 2005 Dr. Janet Woodcock verbalized FDA’s vision on pharmaceutical risk based cGMP’s for the 21st century as follows: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
The International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) supports this vision with ICH Guidelines Q8, Q9, Q10, Q11 and Q12. The ICH Q10 Guideline titled Pharmaceutical Quality Systems pointed out the need for a lifecycle approach, with “Elements and Enablers” to assure a high-quality production environment.
The new ICH Q12 Draft Guideline is focusing on the change management to increase flexibility.
The ISPE Special Interest Group “Pharma 4.0” published in 2017 an award-winning article in the magazine “Pharmaceutical Engineering” on how ICH Q10 can be enriched with additional “Elements and Enablers” to make this guideline benefit from new technologies. The four “Elements” of the operating model and the “Enablers” data integrity by design and digital maturity are pictured in ISPE’s Pharma 4.0 operating model.
The Quality Management process in Pharma 4.0 is based on ICH Q10: Pharmaceutical Quality System (Picture 2).

ICH Q10 Pharmaceutical Quality System – ICH Q10

The ICH Q10 PQS Model as stated in Picture 2 is now enhanced by the new Pharma 4.0 Enablers and Elements which are needed to manufacture the product. Refer to Picture 3, Enablers & Elements from ICH Q10 are colored in grey, new Enabler and Elements are designed in blue. This model describes now a PQS and a control strategy across the complete product lifecycle consisting of the submission based control strategy and the manufacturing control strategy.

Holistic Product Lifecycle Control Strategy management (PLCM) (Source: ISPE SIG “Pharma 4.0”)

The new Elements are the four quadrants of a company’s operating model consisting of the additional pharma specific capabilities of digitalization. The new pharma specific Enablers are “Digital Maturity” and “Data Integrity by design”. Together they form a Holistic Control Strategy for the complete product lifecycle. This Holistic Control Strategy requires information exchange into the decision hierarchy, along the value chain and across the value network.

Digitalization requires interdisciplinary collaboration

This will be a disruptive change for pharma, as the Digitalization is impacting all business areas of the Business Processes Design, Realization and Execution to build the Holistic Control Strategy. This is paving the road for a 6Sigma approach for the pharmaceutical industry. This is different from the past, where the paper based processes in pharma did not support a transparent, flexible and agile approach.

Design, Execution, Realization – the collaborative value chain network building the Holistic Control Strategy (Source: ISPE SIG “Pharma 4.0”)

The goal of the ISPE’s Special Interest Group Pharma 4.0 and its Sub-Groups, is to provide industry wide, accepted implementation methodologies, approaches and case studies on how to evolve life science organizations to Pharma 4.0.

About the Author

Christian Woelbeling is Senior Director Global Accounts at Werum IT Solutions based in Lueneburg, Germany, Werum is part of the Körber Medipak Systems Group and is the market leader in Manufacturing Execution Systems / MES Solutions for the Life Science industries, working for 17 out of the Global Top 30 Pharma Companies with more than 800 installations.
He holds a Master Degree in Mechanical Engineering from Hamburg University of Applied Sciences, Germany.
Since more than 26 years, working with Werum in Life Sciences Manufacturing IT, Christian has large experience in all GMP related processes.
He has broad activities inside the International Society of Pharmaceutical Experts / ISPE as Chairman of the Special Interest Group “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “Knowledge Network Council” Co-Chair and ISPE Affiliate DACH Board Member.
Christian Woelbeling has been part of the annual we.CONECT Pharma MES Berlin conference since the very beginning, almost 7 years ago. For the past years, up until today, he has been part of the Pharma MES Advisory Board and supports we.CONECT in pointing out hot industry topics and aligning top-notch speakers for the annual Pharma MES Berlin program.

  1. International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q10 – Pharmaceutical Quality System, Quality Guidelines; June 2008
  2. acatech Study, „Industrie 4.0 Maturity Index Managing the Digital Transformation of Companies” Günther Schuh, Reiner Anderl, Jürgen Gausemeier, Michael ten Hompel, Wolfgang Wahlster (Eds.),
  3. ISPE Award Winning Article: “A Holistic Approach To Production Control” From Industrie 4.0 to Pharma 4.0; Dr. Christoph Herwig (TU Vienna), Christian Wölbeling (Werum IT Solutions), Dr. Thomas Zimmer (ISPE)