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Pharmaceutical & Biotechnology Industry Forum John Danese, CPIM 16-17 April 2007 Life Science Strategy Director Mainz, Germany
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Topics
Supply Chain Management Strategy Manufacturing Strategy Regulatory Compliance
Benefits
Reduce risk by
Minimizing data redundancy Reducing system complexity Enforcing manufacturing best practices Tracking all manufacturing actions in an electronic batch record Automating approvals
E-Records Enhancements
Enhanced auditing with relining Additional approval methodologies Streamlined approvals
Increase speed of approvals Improve collaboration Simplify auditability of changes to critical data Reduce Risk by providing a single source of truth for inventory Improve efficiencies with automated warehouse task management Support postponement with better inventory information
Provide the broadest integrated drug development to commercial manufacturing platform Provide the deepest in-suite manufacturing execution capabilities of any top tier ERP Build configurable compliance into the platform
150 100 50 0
Strong Weak
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Measure Stock Turns On Time Full Delivery Equipment Utilization Demand Forecast Accuracy
Pharma Industry 3 to 5
World Class Factory 50 $91B 99.6% 92% 3X more output 75% - 85%
Source: R. S. Benson and D. J. MacCabe. From Good Manufacturing Practice to Good Manufacturing Performance Pharmaceutical Engineering. July/August 2004.
Source: AMR Benchmark Analytix
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Supply Planning
Constraint-Based Consensus Consensus Forecast Forecast
Production Scheduling Strategic Network Optimization
S&OP Meeting
New Product New Product Forecasting Forecasting S&OP Review S&OP Review Promotion Planning Promotion Planning Evaluate Supply Evaluate Supply Constraints Constraints
Execute
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Day 30
Collect Demand
S&OP Meeting
Publish Plan
Day 30
Collect Demand
S&OP Meeting
Publish Plan
Automated approval process with role-based consensus process enables agility to respond to changes
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Day 30
Collect Demand
S&OP Meeting
Publish Plan
Manufacturing disruption
Day 30
Collect Demand
S&OP Meeting
Publish Plan
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Day 30
Collect Demand
S&OP Meeting
Publish Plan
Manufacturing disruption
Day 30
Collect Demand
Collect Demand
Publish Plan
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Demand Visibility
Supply Visibility
Contract Manufacturing
Suppliers
Deep Manufacturing
EDW
SFA/CRM
? ?
S&OP
PLM
ERP
AMR Research
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Supply Chain Execution Manufacturing Order Management Shipping Execution Logistics Finance Financial Planning and Budgeting
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DM
Planning
APO
RT S&OP
TPMO
Execution
R/3
Back Office Front Office
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ERP/SCM/Planning
Level 3
Level 2 Level 1
Batch Control Continuous Control Discrete Control
HMI/MMI/SCADA Level 0
Actual Production Process
* Future
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R12.1
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Devices
3rd Party Integration
Devices
Oracle Edge Server MES for Process
MES
Web Services
OPM
OPM
Existing Process Manufacturing Suite
OPM
OPM + integration other MES
APIs and Web Services enable integration based on S95
OPM
OPM + MES for Process
Process Instructions & SOPs, Dispensing, Nonconformance Mgmt., Electronic MBR and CBR, Mobile, Labeling, Device Integration
Production Supervisor
Log Nonconformances Dispense Ingredients Lock Operation, Follow PI, Execute Tasks
Dispensing
Schedule Batch & Reserve Materials
Production Operator
Processes batch operations
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Dispensing R12.1
Touch Screen Enabled
Supporting Deep Manufacturing Operations Management Process guides move operators through work instruction view, progress reporting, and material consumption tracking Quality data collection and lot data capture for genealogy Integration to process equipment
Complete Process Support for Work Instruction Display, Dispensing, Batch Progress Tracking, and Ingredient Consumption Reporting
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Material &
Material &
Resource
S e c urity
O r a c le F u s io n M id d le w a r e A d a p te rs B2B B P EL P M
Resource
BAM
M e ssa g ing
T r a n s f o r m a t io n
R o uting
O r a c le E n t e r p r is e S e r v ic e B u s
Completion
Production
Production
Schedule
B2MML
B2MML
MES
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MES
Corporate Plant
EMI Hub
Device Data Actual Counts Actual Times Parameter Values Actual Scrap Equipment Status
Automation & Control Historian SCADA PLC
S-95
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Regulatory Compliance
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ePedigree
Technology Partner initiatives
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Drug Counterfeiting
Cumulative US Counterfeiting Losses: Over $1 Billion Average impact to major manufacturer: $50 to $100 Million annually
7% of the World Drug Supply Chain is Counterfeit Wrong WHO
packaging Wrong ingredient
5%
25 20 No active ingredient 15 10 5 0 6 4 6 6
7%
Sub-potent active ingredient
21%
Poor quality
43%
24%
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Provides the tools necessary for data consolidation and integration Facilitates sophisticated data manipulation, analysis, and reporting Enables better interpretation of data Supports pedigree reporting across the supply chain
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Drive Operational Excellence Enable Regulatory Compliance Manage Supply Chain Risk
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