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

2. 4th HGP Asia Knowledge Day

3. 4th HGP Asia Knowledge Day

5. 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?

6. 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

7. 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
1990s

8. 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

9. 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

10. 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

11. 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

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

13. 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

14. People-And-Processes-First!
People (Organization)
Process
Technology

15. 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

17. Contact
Halfmann Goetsch Partner AG St. Alban-Vorstadt Basel Switzerland
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Thomas Halfmann Partner E T