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Serialisation –status and implications
SARQA, HöstkonferensenMölndal, Sweden
19.11.2015 Søren Andersen
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Who are we?
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• An international company
specialised in Pharma
engineering
• Over 85 years of experience in
Pharma engineering
• Close to 2,000 professionals with
extensive Pharma project
experience and technical
expertise
• Around 3,000 projects per year
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We are focused on Pharma engineering
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• More than 85 years of Pharma and
biotech engineering experience
• 99 percent of our activities in this
industry
• GMP, pharmaceutical process and
business conditions is our daily life
• All of our close to 2,000 employees are
used to working in Pharma
• Leading experts with deep insight in
Pharma engineering
• Many of our engineers have been
working in production or development
Master planning
Critical tasksCore operations validation
cleanrooms
Tech transfer
Quality by design
aseptic environments
API
Drug manufacturing
Devices
Project management
Single-use technology
filling lines
Facility design
Feasibility testing
GMP Utility systems
Basic designHigh potency
Process equipment
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Assisting you within the entire manufacturing lifecycle
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Expert Pharma engineering and consultancy
to support you in all phases of
pharmaceutical production
• Consulting on how to best meet the ever-
changing demands in Pharma production
• Fast-track establishment of
pharmaceutical R&D and production
facilities
• Optimisation and debottlenecking of
ongoing production to meet changing
product, quality, capacity and efficiency
requirements
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Introduction - Serialisation
• “License to Operate”
• GDP/GSP compliance
• RA compliance to Anti-counterfeit laws
• Tender requirements from GPO’s
• Brand protection
• In short:
• Unit Cost and Profitability are
under threat
• Invest is high
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Profitability & Cost
Tender requirements from GPO’s
RA compliance to Anti-
counterfeit laws
GDP/GSP compliance
Brand protection
“Serialisation” is not just solved by
adding another Band-Aid. It’s a long-
term commitment and investment so
why not reach out for World Class
Pharmaceutical Packaging?
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Definitions
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Definitions
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The Chain from manufacture to customer (EU)
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EU Delegated Act is not
100% clear on verification
in the supply Chain
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eLeaflets® are on the move in Australia and EU is working on a
program
for implementationData exchange / fact
based information
Looping back
Continues management
of data
“Meet the Doctor”
• Voice information
• Interactive user guide
• Videos
• Adverse reaction warnings
• “Marketing” of improved
and new products to match
client profile
• Q&A sessions
Serialisation and the opportunities
Knowledge
• Customer interaction
• Real time sales figures
• Faster responsiveness
• Increase customer value
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Serialisation, Traceability and Tamper Verification
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Global Serialisation and Traceability
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Key Serialisation and Traceability Requirements
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Key Serialisation and Traceability Requirements
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Timetables: Europe and Turkey
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Timetables: Asia and Australia
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Timetables: Americas, Russia and Middle-East
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*) Revoked by new bills
Suspended
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Market Specific Requirements
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Market Specific Requirements
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Key Takeaways
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• Global readiness is not only about serialisation
• Traceability
• Tamper evidence/verification
• Partner readiness
• Regulatory reporting
• Implementation orchestration: collaboration internally and
with supply chain partners
• Global requirements are very diverse and fast changing: market
and regulatory intelligence is essential
• Better to be ready early than late – so start preparation
now
• Internal decision making and commitment will take time
• Scope is larger than you might even imagine
• Budgets are big in comparison to the usual production
projects
• New technologies and competences required
• Vendors are already fully booked for 8-12 months
• Your partners may not be ready on timetable
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NNE Pharmaplan Serialisation offerings
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Cu
sto
me
r
Automation & IT• Manufacturing Information
Systems
• PLC/SCADA
• System Interfaces
Finished Products• Packaging line knowledge
• Vendor coordination
• Equipment specifications
• Project Management
Serialisation software• Configuration
• Communications with vendor
• Interfaces to Equipment
• Knowledge of all major SW
GMP Compliance• Validation documentation
• Risk Assessment
• Test Plans
• SOP
Logistic & Warehouse• Product distribution mapping
• Product flow
• Contract packaging mapping
Management Consulting• Change Management
• Training
• OEE
• Performance optimization
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