Lothar Hartmann

PhACT
Managing Director
Lothar Hartmann, PhD, obtained his diploma and PhD in technical chemistry from the Technical University of Berlin. He joined Hoffmann-La Roche in 1988 and served in numerous functions in the global Quality Department. Lothar acted as Head of Pharmaceutical Quality Systems and External Relations and Knowledge Management. In 2011, he became Head of Quality at a large Johnson & Johnson site before he became an independent consultant with PhACT. Lothar has served in numerous organizations such as APIC/CEFIC (Vice-Chair), European Biopharmaceutical Enterprises BioManufacturing Working Group (Chair), and PDA (Board of Directors, Quality Systems Interest Group Chair). Currently, he heads PDA’s Global Interest Group on Quality Systems and is actively involved in ISPE’s Pharma 4.0TM SIG. Lothar was part of the Expert Working Group of ICH Q7a. He has been an ISPE member since 2002.

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The holistic supply chain
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Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™

The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...

Figure 2: ISPE Pharma 4.0™ operating model
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Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...