MES for Pharma and Biotech Manufacturing HGP Asia Knowlegde Day 2017 Thomas Halfmann Partner HGP Group

4th HGP Asia Knowledge Day www.hgp.ag

4th HGP Asia Knowledge Day www.hgp.ag

When and how did it all start? Why MES in Pharma? History of MES When and how did it all start? Why MES in Pharma? How are Pharma MES solutions different from traditional MES solutions? 21st Century Manufacturing IT and Automation Solutions What is the shop floor of the future? www.hgp.ag

History of MES Manufacturing Execution Systems (MES) are computerized systems used in manufacturing, to track and document the transformation of raw materials to finished goods. MES provides information that helps manufacturing decision makers understand how current conditions on the plant floor can be optimized to improve production output. MES works in real time to enable the control of multiple elements of the production process (e.g. inputs, personnel, machines and support services). MES creates the "as-built" record, capturing the data, processes and outcomes of the manufacturing process. This can be especially important in regulated industries, such as food and beverage or pharmaceutical, where documentation and proof of processes, events and actions may be required. … From wikipedia THOMAS www.hgp.ag

History of MES Evolution of MES Activating Data Volume Operationalizing Predicting Process Complexity Analyzing Reporting MIS Manufacturing Information System EMI Manufacturing Enterprise Information MOM Manufacturing Operations Management MES 1990s 2000s 2010s www.hgp.ag 1990s

History of MES When and how did it all start? Level 4 Business Control ERP Level 3 Plant Control PAPER Level 2 / 1 Machine Control Automation SCADA / DCS / PCS www.hgp.ag

History of MES When and how did it all start? Level 4 Business Control ERP Level 3 Plant Control BASIC SYSTEMS PAPER THOMAS Level 2 / 1 Machine Control Automation SCADA / DCS / PCS www.hgp.ag

History of MES When and how did it all start? Level 4 Business Control ERP Level 3 Plant Control MES (EBR) THOMAS Level 2 / 1 Machine Control Automation SCADA / DCS / PCS www.hgp.ag

History of MES Why MES in Pharma? Improved Process Quality Increased Yield / Less Waste Increased “First Time Right“ Increased Compliance Decreased Batch Release Effort Review by Exception Parallel Batch Record Review Increased Efficiency Data Acquisition, Automated KPI Calculation Online Data Decreased Effort Less Effort For Production Preparation Less Effort For Batch Record Review Decreased Double Checks User Empowerment www.hgp.ag

History of MES How are Pharma MES solutions different from traditional MES solutions? transparency efficiency integration user guidance compliance www.hgp.ag

21st Century Manufacturing IT and Automation Solutions What is the shop floor of the future? System architectures will change! Highly integrated systems architecture Cloud solutions Internet of Things (IoT) / Industry 4.0 … Pharmaceutical business models and pharmaceutical manufacturing will change! Continuous manufacturing Personalized medicine End-to-end supply chain visibility … MES / MOM as a concept will be needed! process control & integration user guidance www.hgp.ag

People-And-Processes-First! People (Organization) Process Technology www.hgp.ag

Conclusion The concept of MES is not new, however MES in Pharma is somehow different than in many other industries  focus on compliance Processes are getting more and more complex, data volume is increasing Changes in pharmaceutical business models, processes and technology require a new (technical) concept of MES www.hgp.ag

Contact Halfmann Goetsch Partner AG St. Alban-Vorstadt 94 4052 Basel Switzerland T   +41 61 544 00 00 E info@hgp.ag I www.hgp.ag Thomas Halfmann Partner E thomas.halfmann@hgp.ag T +41 61 544 00 01 www.hgp.ag