Gdp Code Of Practice & Passport Scheme

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GDP Code of Practice & Passport Scheme is aunique initative by Life Science Ireland group within the Irish Exporters Association providing an Information & Training Framework that is full …

GDP Code of Practice & Passport Scheme is aunique initative by Life Science Ireland group within the Irish Exporters Association providing an Information & Training Framework that is full accrediated and supported by Pharmaceutical Regulator

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  • 1. 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
  • 2. P a g e |2 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
  • 3. P a g e |3 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.
  • 4. P a g e |4 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
  • 5. P a g e |5 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.
  • 6. P a g e |6 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.
  • 7. P a g e |7 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.
  • 8. P a g e |8 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.
  • 9. P a g e |9 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
  • 10. P a g e | 10 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
  • 11. P a g e | 11 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.
  • 12. P a g e | 12 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; Company Name: Contact Person: Job Title: Phone Number: Fax Number: Address: E-mail Phone Number: : Signature: Signed By: Date:
  • 13. P a g e | 13 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
  • 14. P a g e | 14 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
  • 15. Driving Export Excellence in Life Sciences Industry A division of the Irish exporters Association