Good Distribution Practice (GDP) Passport Scheme

for Supply Chain Service Providers To The

Pharmaceutical, Medical Device and Diagnostics

Manufacturing Sectors in Ireland

An initiative of Life Sciences Ireland, a forum within the Irish

Exporters Association which represents Pharmaceutical, Medical

Device, Biologic and Diagnostic Manufacturers

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CONTENTS

Introduction __________________________________________ 3

Good Distribution Practice Code (GDP) ____________________ 5

Introduction _________________________________________ 5

Principle ____________________________________________ 5

The Manufacturer _____________________________________ 8

Ports, Airports, Terminal Operators _______________________ 8

Approved Trainers ____________________________________ 8

Application for GDP Passport ____________________________ 8

Inspections __________________________________________ 8

Life Sciences Ireland review _____________________________ 9

Fact sheet 1: GDP Passport Requirements _________________ 10

Fact sheet 2: IMB Wholesalers + GDP Passport _____________ 11

GDP Passport Application ______________________________ 12

Irish Exporters Association Background __________________ 13

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Introduction

Ireland is one of the leading international locations for the Life Science industry.

The industry which spans pharmaceuticals, chemicals, diagnostics, medical devices

and biotechnology generates over 50% of our exports making Ireland the largest

net exporter of medicines globally. Ireland is home to 13 of the top 15 companies

in the world and manufactures 9 of the world‘s top 15 medicines. In 2008 there

were over 24,500 people employed in the sector producing exports of over €44

billion. Globally the sector has been expanding by 5-6% per annum since the turn

of the decade, and last year recorded global sales of US $745 billion. By

comparison exports of Life Sciences products from Ireland have more than doubled

in the same time frame and now account for 9% of global sales.

For any Life Science (Pharmaceutical, Medical Device, Biologic and Diagnostic)

manufacturing and supply chain companies, the safe and effective distribution of

their products to the ultimate patient is crucial. This represents a significant

challenge since the Life Science Sector also has to operate in a highly regulated

environment, not least of which is the increasing compliance requirements for an

international temperature controlled supply chain. The industry has indicated that

in the UK over the next 2 to 3 years up to 50% of all newly approved medicines will

be temperature-sensitive biopharmaceutical products.

At the beginning of 2008, the World Health Organisation (WHO) published a

document titled ―Good Distribution Practices (GDP) for Pharmaceutical Products‖ for

commenting on by end of March of this year. This guidance is the counterpart of

the document ―Good Trade and Distribution Practices for Pharmaceutical Starting

Material‖, which was published by the WHO in 2003. At European level, the EU

published its ―Guidelines of Good Distribution Practice of Medicine Products for

Human Use‖ (94/063/3) dating back to 1992.The International Air Transport

Association (IATA) introduced a new set of regulations for airlines and ground

handlers on the 1st July 2009 to counter a pharmaceutical industry report that

suggested that 50% of temperature deviations occur when the consignments are in

the hands of the airlines and their facilities.

All of these international bodies have indicated the need for guidance on a range of

distribution practices for the Life Sciences industry. These can generally be

summarized as laying down requirements for the supply chain service providers to

improve the management of the following:

Quality systems, organizations and personnel, in the supply chain.

Premises and storage areas

Transport vehicles, external packaging and shipping practices

Temperature controlled transport handling and dispatch areas, as well as

temperature mappings to verify compliance

Counterfeit identification

Exports/imports and sub-supply routings

Life Sciences Ireland was established by the Irish Exporters Association (IEA) two

years ago to address these issues and to develop and deliver training for the

logistics, transport and storage industry; In the process ensuring that the

manufacturers in the sector in Ireland could lead the way by ensuring a regulated,

safe and efficient supply chain system for getting their products delivered to

international markets and the consumer in those markets.

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We wish to thank the input of the Department of Enterprise, Trade and Employment

for its assistance and support through the Accel funding scheme during the early

stages of the training development and pilot delivery. To ensure that the training

and recommended procedures promulgated through these courses were up to the

necessary standards, the IEA carried out an extensive review process with the Life

Sciences manufacturers across Ireland. This resulted in a set of guidelines which

are encapsulated in the GDP Code of Practice which is set out in this publication.

The IEA consulted with the Irish Medicine Board during the process of developing

the GDP Code and welcome their input and support for this Code. We are confident

that the Code and the training practices that go with it, will help to ensure that

Ireland remains the preferred location for Life Sciences companies to develop,

manufacture and distribute their products internationally.

John F Whelan Chief executive Irish Exporters Association

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Good Distribution Practice Code (GDP)

Introduction

This Code of Good Distribution Practice (GDP) arose from the need for all

stakeholders in the Life Science (Pharmaceutical, Medical Device, Biologics and

Diagnostic) industry to work in partnership to ensure supply chain integrity. The

intention is to ensure as far as possible, only bona fide suppliers and customers are

allowed to import, export, and supply and distribute life sciences products in and

out of Ireland. The primary intention is to support the industry and the Competent

and Notified Authorities to guarantee patient safety at all times along complex

global supply chains. Those responsible for ensuring supply chain integrity

(Licensed GMP Manufacturers and Authorised Wholesalers) need to ensure that all

service providers to the life sciences industry understand the fundamentals of a

secure and safe supply chain of medicinal products for human use. By adopting the

Good Distribution Practice (GDP) Code described herein, manufacturers can ensure

that their products arrive with the final customers in perfect condition, as

prescribed for human use. This Code builds on the IEA‘s existing programme to

drive excellence in the supply chain for the Life Science sector in Ireland. The Code

is focused at providing training courses to all levels of personnel involved in the

supply chain. The key to success is the full suite of standardised and certified

training which is to be undertaken by all those engaged either directly by the

manufacturer or indirectly by the Service Provider so that full visibility and

responsibility is clear throughout the entire supply chain.

Principle

Primary suppliers engaged in transportation and/or warehousing/ logistics of Active

Pharmaceutical Ingredients (API‘s), Finished Pharmaceutical, Medical Devices, and

Diagnostic Products should either obtain;

A Wholesalers Licence (recently re-named Wholesalers Authorisation ) from

IMB or

A Good Distribution Practice (GDP) Passport Licence from Life Sciences

Ireland

To qualify as a Wholesaler Licence holder a company must satisfy the Irish

Medicines Board‘s (IMB) guidelines on Good Distribution Practice and successfully

pass an inspection.

To become a GDP Passport Licence Holder, the following is required:

1. The Service Provider must appoint a management representative at each

distribution point as the in-house GDP Champion who is responsible for

working closely with manufacturers and an approved GDP Trainer to ensure

the company meets the requirements of becoming a GDP Passport Holder.

The GDP Champion has the responsibility of being the key point of contact

on all compliance and quality aspects on behalf of manufacturers and will

work to continually improve GDP practices along the supply chain.

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2. Key personnel involved in the warehousing of medicinal products should

have the appropriate ability and experience to guarantee that the products

or materials are properly stored and handled in compliance with the

manufacturers‘ specifications.

3. Personnel should be trained in relation to the duties assigned to them and

the training sessions should be backed up by records.

Premises

4. Premises (Storage), Equipment (e.g. Transportation) & Processes (Quality

System in place, security controls) must meet a set of criteria which follows

the minimum standards set out under the EU Guidelines on GDP or FDA/

GMP requirements.

5. Medicinal products should be stored apart from other goods and under the

conditions specified by the manufacturer, in order to avoid any deterioration

by light, moisture or temperature.

6. The storage facilities should be clean, free from litter and dust and pests.

7. When specific temperature storage conditions are required, storage areas

should be equipped with temperature recorders that will indicate that the

required temperature range has been maintained.

8. Medicinal products with broken seals, damaged packaging or suspected of

possible contamination should be notified to the Manufacturer, and kept in a

clearly separated area awaiting the Manufacturers disposal instructions.

Transport and Vehicles

9. Medicinal and medical device products should be transported in such a

manner that;

a. Their identity is not lost

b. They are not contaminated, and they do not contaminate other

products or materials.

c. Adequate precautions are taken against spillage, breakage or theft.

d. They are secure and not subject to unacceptable degrees of heat,

cold, light moisture or other adverse influence, or to attack of micro –

organisms or pests.

e. Medicinal products requiring controlled temperature storage should

also be transported by appropriate means.

Procedures and Records

10. Written procedures should describe the different distribution activities such

as;

a. Receipt and checking of deliveries,

b. Storage, cleaning and maintenance of premises ( including pest

control)

c. Recording of storage conditions, security of stock on site and of

consignments in transit

d. Withdrawal from stock, records of client orders, returned products,

recalls etc.

e. These procedures should be signed and dated by the person assigned

as the GDP Champion.

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f. Records should be made each time and operation is undertaken, in

such a way that all significant activities are traceable.

g. Records should be clear and readily available.

h. Records should ensure the traceability of the origin and destination of

each product.

Training

11. To become a GDP Passport Licence Holder a Service Provider must be

capable of demonstrating that all relevant personnel are trained to an

acceptable level on Good Distribution Practice and that their premises and

vehicles meet minimum operational/compliance standards. The GDP Licence

will be valid for 2 years (24 months from date of issue.)

12. GDP Passport Training has 3 stages

a. A GDP Champion is nominated (this person is involved at a supervisor

level) and undertakes the 3 day Intermediate Training Programme

b. Half day training in GDP is completed by operational staff working in a

warehousing/ facility.

c. For transportation drivers a 2 hour training course needs to be

completed.

13. All courses include assessment to demonstrate in keeping with regulator

requirements that learning has taken place.

14. All participants have to successfully complete a set of questions on the

training courses provided and all records of the course and assessment form

part of the individuals training records. Certification is provided for each

participant who has successfully completed these courses. Certification is

valid for one year.

15. Temperature Control Logistics - Where the manufacturer requires

temperature controls over the transportation or storage of their goods then

the GDP Passport Holder is required to hold a joint GDP/TCL Passport.

16. Once a Service Provider meets the requirements set out above (premises,

training, equipment) they will be issued with a GDP Passport Licence.

17. Renewal of GDP Licence

a. Refresher training must be undertaken on a bi-annual basis. This will

enable Service Providers to get a renewal of their DGP License.

18. GDP Transport Card

All of the companies‘ drivers assigned to the collection and delivery of

Pharmaceutical, Medical Device and Diagnostic Products (PMD & DP) will be

issued with a valid GDP Transport Card following completion of their

training. This Card must be produced on arrival at the factory (warehouse)

gate of the PMD&DP customer.

19. Service Provider Sub Contractor and third part Service Companies Where a

Service Provider subcontracts road transport activates, they must ensure

that all third party drivers hold a GDP Transport Card, otherwise they will

not be allowed entry to the PMD&DP manufacturers or storage facility to

deliver or collect products.

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The Manufacturer

Within the Warehouse/Storage/Logistics areas of manufacturing companies it is

recommended that all personnel handling products must receive GDP training. This

will ensure consistency of GDP standards is in place as products are collected and

moved along the supply chain to final delivery destination. This is necessary to

ensure that the overlap between the standard operating procedures (SOPs) related

to receipt, storage, handling and transportation under GMP guidelines match the

appropriate minimum SOPs for the service providers and that the quality of

transportation fully meets the essential standards of compliance and security and

product integrity as products move along the supply chain.

Ports, Airports, Terminal Operators

Within the Warehouse/ Storage/ Logistics areas of Airports, Sea Ports, Sea and Air

Terminal operators, it is recommended that all personnel managing their facilities

must receive GDP Training. This is to ensure adequate and consistent availability of

facilities to handle medicinal products which are handled, stored, or transit these

areas.

Approved Trainers

The Life Sciences Ireland Steering Committee has approved a number of Trainers to

carry out the training requirements of the GDP Licence / Passport system. Only

companies approved by the Life Sciences Ireland Steering committee may be

engaged to conduct the training. The approved trainers are also certified by

Institute of International Trade of Ireland (IITI).

All training providers will be obliged to ensure that the training content meets the

guidelines as set out by the IMB/EU/FDA and World Health Organisation (WHO)

minimum requirements for companies to remain compliant under their

manufacturing or wholesale authorisation licence in relation to the handling,

storage and transportation of Medical Device, Pharmaceutical or Diagnostic

products.

Application for GDP Passport

Firms wishing to become GDP Passport holders are invited to submit their

applications to the Director, Life Sciences Ireland, Irish Exporters Association, 28

Merrion Sq, Dublin 2, Tel: 01 6612182, Fax: 01 6612315 Email:

lifesciences@irishexporters.org

Inspections

Inspections of facilities will be based on records of prior inspections carried out by

IMB, or the Manufacturers and /or by an approved Life Sciences Ireland inspector.

Each Service Provider will be requested to supply evidence of any inspections

carried out on their facilities over the past 2 years by any authorised bodies, as part

of the process of GDP Licence application.

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Life Sciences Ireland Review

Life Sciences Ireland is an industry grouping within the Irish Exporters Association.

The broad focus of the grouping is to support multinational and indigenous life

sciences companies in their international trade and supply chain activities and to preserve the sector‘s status as Ireland‘s fastest growing export grouping.

Specifically, the Life Sciences Ireland grouping is focused on driving export excellence in life sciences by supporting the following critical business areas:

1. Good Distribution Practices – Benchmarking the standard for the industry

and promoting its use by all service providers nationally and internationally.

2. Logistical Efficiency - promoting and providing access to the latest cost

reduction and supply chain efficiency improvement techniques and

opportunities.

3. Material Quality Control – assisting life sciences companies and those

serving the industry to keep up to speed in the latest material handling and

environmental control methods and standards.

4. Regulatory Response – providing training and support to enhance the

sector‘s ‗rapid response‘ capability to changing regulations and standards.

5. Good manufacturing Practice – supporting companies achieve and

maintain their GMP standards in line with IMB and international regulatory

body requirements.

6. Lobbying - ensuring that companies within the sector in Ireland have the

opportunity to have their views represented at WHO, EU and national

government to ensure any new or proposed changes to legislation are efficiently processed.

For more information contact; The Director, Life Science Division at;

28 Merrion Square, Dublin 2, Ireland.

Phone; +353-1 6612182; e-mail: lifesciences@irishexporters.org

www.irishexporters.ie/lifesciences.shtml

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Fact sheet 1: GDP Passport Requirements

A Code of Practice – Good Distribution Practice (GDP) for Logistics Service Providers

(Transportation, Warehousing and Storage) has been drawn up and approved by

the Pharmaceutical Manufacturing & Medical Device Sectors This Code of Good

Distribution Practice (GDP) arose from the need for all stakeholders in the Life

Science Industry (pharmaceutical, medical device, biologics and diagnostics) to

work in partnership to ensure supply chain integrity. The intention is to ensure as

far as possible, only bona fide suppliers and customers are allowed to import,

export, supply, and distribute life sciences products in and out of Ireland. The

primary intention is to support the industry and the authorised authorities to

guarantee patient safety at all times along complex global supply chains. Those

responsible for ensuring supply chain integrity (manufacturers and wholesalers)

need to ensure that all service providers to the life sciences industry clearly

understand the fundamentals of a secure and safe supply chain of medicinal and

medical device products for human use. By adopting the Good Distribution Practice

(GDP) Code manufacturers can ensure that their products arrive with the final

customers in perfect condition, as prescribed for human use.

What is required to gain GDP Passport Accreditation ?

o Appointment of GDP Champion – must have completed an intensive 3 Day

GDP Training Module

o All relevant Warehouse Staff completed 1 day GDP Introduction Program

o All Drivers involved in Transportation & Handling of Pharmaceutical Products

must complete 2 Hour Driver Training

o All training must be given by Certified Institute of International Trade of

Ireland IITI (training body of Irish Exporters Association IEA) Trainer

o Code, the facility to review Service Providers training records.

o Drivers will receive a GDP Card valid for two years.

o Manufacturers will require Drivers to produce their GDP Card on arrival at

the Factory Gate.

o Each location / branch needs to have an appointed GDP Passport Champion

and undergo premises inspection or can demonstrate that their premises

meet the required Life Science Standards.

o Formal Certificate of Accreditation will be presented by IEA

o Passport is valid for two years and renewal will require refresher training.

The Code of Practice was developed in consultation with the Irish Medicines Board

(IMB) and all training is designed to meet the training requirements as set out in

the IMB‘s GDP Guidelines ~ Wholesaler Authorisation. All Training is accredited by

the Institute of International Trade of Ireland (IITI).

For information of the above please contact ;

The Director , Life Sciences Director

28Merrion Square, Dublin 2. ----Email: lifesciences@irishexporters.org

Phone: +353-1 6612182

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Fact sheet 2: IMB Wholesalers + GDP Passport

IMB Authorised Wholesalers who wish to apply for GDP Passport must proceed as

follows:

1. Formal letter of application plus GDP Passport Application Form

2. Receive auditor from Life Sciences Ireland who will:

a) Inspect IMB Wholesalers licence and record reference number and

validity dates.

b) All GDP training records including driver training.

3. The Life Sciences Auditor will send back report on a) and b) above and a

recommendation as to whether to issue GDP Passport, and which drivers to be

covered by the GDP Driver Card

4. The IMB Wholesaler will then be issued with an invoice for the work carried out

above.

5. Finally the IMB Wholesaler will be issued with a GDP Passport and Driver GDP

Card.

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GDP Passport Application

We wish to apply for a GDP Passport. Please find below the information needed in

order to start the process to obtain the GDP Passport:

Attn; The Director, Life Sciences Ireland, 28 Merrion Square, Dublin 2

e-mail: lifesciences@irishexporters.org

Phone: +353-1 6612182

I wish to apply for a GDP Passport, please advise me of the process.

My contact details are;

Signature:

Signed By:

Date:

Company Name:

Address:

Phone Number:

Phone Number:

Fax Number:

Contact Person:

Job Title:

E-mail :

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Irish Exporters Association Background

The Irish Exporters Association, was incorporated in May 1951, has a buoyant

membership base and is actively engaged in promoting the best conditions for

exporting companies in Ireland. Our membership is comprised of exporters of

merchandise, services and export service providers from all sectors of Irish

business, multi-nationals and indigenous SMEs.

Overview of IEA Membership Benefits:

Provides a Voice to all those in Export Industry

Represent members‘ interest at the highest level

Key Networking Opportunities

Expert Assistance on International Trade matters

Frequent Publications on Export issues

Regular Ezines on latest National and International Developments

Free/ Discounted Export Training Programmes

Discounted Services to Members

Notification of Business Opportunities

Visa / Export Documentation Legalisation

Brand audits and clinics

Export Direct out sourcing support Services

Export Market Development Programmes

Channel Development Clinics

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The IEA offers tailored assistance and support to each company who applies for

membership. Tailored services include;

Market Entry Strategy—we assist companies to devise their best market

entry strategy for their chosen markets.

Channel Strategy—focused programmes are available to assist companies

use best practice in managing the process to getting listed, and building

business in new Channels.

Full Marketing Cycle –we offered funded programmes to enable companies

to review their full marketing cycle, identify gaps in the capabilities and put

mentors/ consultants working with the business to address the gaps, and

expand business.

Logistical Efficiency – we promote and provide access to the latest cost

reduction and supply chain efficiency improvement techniques and

opportunities.

Material Quality Control – we assist food & drink companies and those

serving the industry to keep up to speed in the latest material handling and

environmental control methods and standards.

Good Distribution Practices – Benchmarking the standard for the industry

and promoting its use by all service providers regionally and internationally.

Regulatory Response – we provide training and support to enhance the

sector‘s ‗rapid response‘ capability to changing regulations and standards.

For more information you can visit www.irishexporters.ie or call us on +353-1

6612182

If you wish you can also send us an email to iea@irishexporters.ie

Driving Export Excellence in Life Sciences Industry

A division of the Irish exporters Association