a 'smart' approach to the introduction of serialisation in pharmaceutical corporations

A Smart Approach to the Introduction of

Serialisation in Pharmaceutical Corporations

Eur Ing Charles A. Smith CEng MIET MInstMC

1 Horizon 2014

http://www.teamhorizon.ie/http://www.teamhorizon.ie/

Who are Horizon?

Horizon are an Engineering & Consultancy Company

Key areas of activity:

SMART Serialisation : from audit to validation, customised

or turn key projects

SMART Manufacturing

Provide a range of other Engineering solutions

-

Ireland - Benelux - France

Horizon 2014

http://www.teamhorizon.ie/

Agenda

International Regulatory Drivers for Serialisation

Business Drivers for Serialisation

Serialisation Terms

Global Differences in Requirements

Key Influencing Factors

Process Mapping

Risk Assessment

Best Practices for International Serialisation Projects

Horizon 2014


International Regulatory Drivers for

Serialisation

Counterfeit Drugs

Dangers

No actual active ingredient

Wrong strength (too high/low) of active ingredient

Drugs contaminated with dangerous materials

Expired Drugs can be toxic

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Serialisation

Counterfeit Drugs

Increasing level of counterfeit drugs in the supply chain

World Health Organisation report of counterfeit levels:

1% in developed world

10% global

Higher in regions - Asia, Africa and Latin America

Estimate that up 50% of drugs purchased on the internet are

counterfeit

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Serialisation

Counterfeit Drugs

Last 4 years Interpol Police

action on counterfeit websites

2009 153 sites shutdown




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0

5000

10000

15000

20000

2009 2010 2011 2012

Shut Down Web Sites



Serialisation

Drug Reimbursement Fraud

Many countries have seen multiple claims for the same

issued drug

No unique numbering on the issued drugs - difficult to

check multiple claims

Significant cost of fraudulent claims - impacts on care that

can be given to other patients

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Counterfeits from an Industry Perspective

Corporations seeing more counterfeits returned as Customer Complaints and via notifications from Ministries

of Health.

Overall appearance of counterfeits improving

Potential for counterfeits to both damage the Corporations reputation and cause product recalls

Transfer of products to other markets

Relabeling of expired product

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Recent Counterfeit Examples

July 2013 FDA Roche Avastin Cancer Drug identified via wholesalers in Egypt, Switzerland,

Denmark, UK

Counterfeit BDMI company also handled Amgens Neupogen (white blood cell stimulator) and

Genentechs Rituxan

Aug 2013 Kiev, Ukraine Cascade Medical Products $37m counterfeit products seized no batch

numbers, expiry dates or instruction leaflets

Nov 2013 FDA identify counterfeit herbal and nutritional product contained prescription active

ingredient

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Other business drivers

Recall management easier to identify product distributed

International Supply Chain Management

Reduce the chance of counterfeit product entering the normal

complex supply chain

Improved control of product stock control of expiry status and

inventory at different locations

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Some Serialisation Terms

Serialisation - include a known unique serial number on products

Track (forward) - Determining the downstream locations of products in the supply chain (Where now? Where going?)

Trace (backward) - Identifying the upstream history of where a product has been at what times (Where has it been?)

Aggregation data structure of distributed product (in identified shipping Case/Pallet)

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Serialisation Terms

EPCIS Electronic Product Code Information Services

GS1 International Standards body coding GTIN Global Trade Identification Numbers

Subset NTIN National Trade Item Numbers

AI Application Identifiers 01 GTIN, 10 Batch, 17 Expiry Date, 21 Serial Number

GLN Global Location Numbers

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GS1 DataMatrix ECC200

GS1 128 Linear

RFID Examples

SSCC Mixed Pallets


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Global Serialisation Activity

Aggregation Serialisation Serialisation under discussion


Key Recent Regulation Developments

US HR 3204 Drug Quality & Security Act - Nov 2013

2017 - Manufacturers to include SNI (US product code), Lot, Expiry Date to Cartons and Shipping Cases.

Manufacturers must provide in electronic format a

Transaction History at Lot Level (not sGTIN or serialised

SNI). Moving to verification at point of dispense.

2023 - Full aggregation in place throughout all distribution phases

Likely to pre-empt Californias Electronic Pedigree Rules

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Key Recent Regulation Developments

Brazil Anvisa Serialisation / Track & Trace Dec 2013

3 Years - Manufacturers to include Unique Medicines Identifier

(UMI) which includes Serial Number, Lot, Expiry Date and

Anvisa Registration Number (Brazils product code) as 2D data

matrix and human readable form to hospital packs.

Deadline of 2 years for Pharmaceutical Companies to submit a

comprehensive report on the traceability of at least 3 batches

which will be submitted to the Anvisa technical committee

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Key Regulation Developments

European Union Falsified Medicines Directive 2011/62/EU

Prescription medicines to include safety features Unique serial number on each carton allowing verification at point of dispense

Tamper Evident Packaging

To be implemented as delegated act for EU Countries (expected 2014) with date of application 3 years after publication

Two European wide traceability repositories for drug data under development to allow connection to national databases

European Directive for the Quality of Medicines & Health Care (EDQM) - eTACT system trial

European Federation of Pharmaceutical Industries and Associations (EFPIA) European Stakeholder Model (ESM)

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SKU Stock Keeping Unit Which countries?

On which packaging lines?

Manufacturing in which countries?

Cold Chain or other Features?

New Product Introductions Build in serialisation to design

Packaging / Labelling Design Larger area needed for printing

Must be visible for scanning

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Equipment Aspects

Age of actual packaging lines

Upgrade or replace?

Physical layout/space for new

equipment

Equipment Capability printers

larger higher resolution Images

Reject Mechanisms

Equipment must be flexible and

configurable dependant on SKU /

country of export



Production Schedule

Spare capacity on lines

Production to stock for customer

supply forecasts

Plan for equipment modification

Allow for lower operational

efficiency during starting phases

Highest speed lines in continuous

use so difficult to schedule

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Resources Corporation resources

Equipment Supplier Capacity

External Systems Specialists

Infrastructure EPCIS

Serial number provisioning

Solutions across manufacturing and warehousing

Existing ERP / Warehouse Systems and Master Data



Validation Full development lifecycle driven by

risk assessment to show the systems

reliably meet their intended design

Standardisation where possible to

allow common unit testing

Configurable design with associated

testing to show functions for different

SKUs / countries

Change control to track different

Ministry of Health requirements

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Process Mapping

Process Mapping allows better understanding of existing process

(current state) and how it can be modified

(future state)

Multidiscipline team equipment / automation / computer specialists,

operations safety needed to reflect:

Physical actions (SOP), equipment steps, communications, and master data

Process phases Batch Setup, Normal batch operation (rejects, sampling) and end of

Batch Processing

Even manual processes can be quite complex

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Process Mapping

Process Mapping needs to consider different levels and may need a different

expertise as part of project team:

Machinery level automation and integration with printing / vision systems

Plant Level systems how serial numbers are locally provisioned, and posting of serialisation code activation, commissioning and destruction to EPCIS

servers

Warehouse systems to support the distribution process after product leaves the manufacturing areas covering pallet and shipping case handling with

exceptions like product returns or physical damage

Corporate level interfaces from EPCIS servers through to the required Ministry of Health Repositories.

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Risk Management

A formal technique of risk analysis like FMEA (Failure Mode and Effect

Analysis) provides a suitable method

of methodically reviewing the potential

risks associated with system

modifications for serialisation.

A multidiscipline team reviews the process maps step by step through

stages of the process

For general guidance risk analysis see ISPE GAMP 5 Section 5 and

Appendix M3 or ASTM E2500

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Risk Management

For FMEA, the review looks at the stages in the process, the equipment / process

involved, the effects, ranking of severity, causes and probability of occurrence,

and the probability of detection to give a Risk Priority Number

At a higher project level, other risks also needs to be considered

Effective management project sponsorship

Project team members with insufficient experience / technical knowledge

Lack of user input from project stakeholders 3rd Party Service Providers (for

example distribution), Corporation Staff in other countries, outsourced

manufacturing companies, computer support groups and service levels

Learn the lessons from the Corporations Phase 1 Projects (Turkey / China)

Suppliers failing to deliver on time (supplier audit)

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Risk Management

Specific Risks for serialisation include:

Operation of Packaging lines become dependant on the reliable operation of

computer servers and infrastructure.

Data loss associated with serialisation may require the potential reworking of

product

There is a potential for scope changes due to the evolving requirements

from National Ministries of Health

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Some Best Practices for International

Serialisation Projects

Some specific best practices are suggested for Multinational Projects:

Note the cultural and operational differences faced by projects spanning multiple countries. The ISPE Good Practice Guide - Global Information

Systems Control and Compliance provides some practical guidance

Put in place a strong project management team capable of handling the range of technologies from Enterprise Level critical data management and

infrastructure, to equipment level packaging equipment.

Consider an early supplier assessment/audit of key system suppliers to confirm that they have the capability to support, not only your corporations

requirements, but also their existing commitments to other customers.

Also at an early stage, develop a realistic project plan to execute such a complex project within the production constraints of market supply.

Horizon 2014


26 Horizon 2013

Any Questions?

We can answer your specific

Questions or Needs

At PharmaPack booth 735


a 'smart' approach to the introduction of serialisation in pharmaceutical corporations

Documents

counterfeit horizon

serialisation counterfeits

serialisation business

smart serialisation

introduction of serialisation

counterfeit products

level of counterfeit

sites shutdown horizon