4. Logistics

4.1 Logistics – General

4.2 Logistics – Consumables

4.3 Logistics – Medical Equipment

4.4 Logistics – Pharmaceuticals


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4.1 Logistics – General

These general requirements apply to all consumables, medical equipment, pharmaceuticals and other medical donations. 
Guidance: The resources below provide comprehensive guidance for medical donation logistics.
Resources 4.1 General
Storage, Distribution, and Dispensing or Medical Supplies Resource Type: Report This report describes the proper storage, distribution and dispensing of pharmaceuticals. This is an excellent resource for anyone wanting to learn more about the logistics around pharmaceutical donations.
Source:This Article is brought to you for free and open access by CREATE Research Archive. It has been accepted for inclusion in Non-published Research Reports by an authorized administrator of CREATE Research Archive. For more information, please contact gribben@usc.edu.
Available at: http://research.create.usc.edu/cgi/viewcontent.cgi?article=1163&context=nonpublished_reports  Accessed on: 02/25/16.

Top 4.1.1 General – Packaging
    Packaging can be one of the most complicated aspects of medical donations. Access to high quality medical products can be compromised when proper packaging procedures aren’t followed.
    4.1.1.1 Prior to making a donation the MSRO should work with the recipients to make sure that packaging, labeling, maintenance and operating instructions (when applicable) is able to be understood by the recipient organization. 4.1.1.2 Protective packaging should take account of the mode of transportation chosen, e.g. glass syringes and bottles must be packed to avoid breakage.

    Guidance: Building and maintaining strong relationships with in-country recipients, as well as, Ministry of Health and government officials will ensure products arrive safely at their destination. Using a medical translation service is a good option for recipients who don’t have fluency in packaging language. When planning a donation process, the MSRO should ensure the recipient or transportation service have the appropriate transport mode available to transport product to final destination safely.
    Resources 4.1.1 Packaging
    UPS: How to Prepare for Shipping Resource Type: Guidelines This website was created by UPS and provides guidelines for properly packaging a shipment. The guidelines include information on providing proper internal protection, as well as, proper labeling.
    Source: UPS. How to Prepare for Shipping: Step-by-Step Instructions. Available at: http://www.ups.com/content/us/en/resources/ship/packaging/guidelines/how_to2.html. Accessed on: 9/18/13.
    Resources 4.1.1.1 Packaging in a Language Understood by Recipient Organization
    International Packaging Symbols Resource Type: Reference Material This website lists several universally accepted packaging symbols.
    Source: technologystudent.com. Ryan V. Symbols-Packaging-2. 2005-2008. Available at: http://www.technologystudent.com/despro2/drink14.htm. Accessed on: 9/18/13.
    International Packaging Symbols – Detailed Resource Type: Reference Material This website lists a wide variety of international packaging symbols. This is an excellent resource for an MSRO wishing to learn more about internationally accepted packaging symbols.
    Source: NEFAB. Packaging Symbols. Available at: http://www.nefab.com/Packaging_Symbols.aspx. Accessed on: 9/18/13.
    Resources 4.1.1.2 Protective Packaging
    UPS: How to Prepare for Shipping Resource Type: GuidelinesThis website was created by UPS and provides guidelines for properly packaging a shipment. The guidelines include information on providing proper internal protection, as well as, proper labeling.
    Source: UPS. How to Prepare for Shipping: Step-by-Step Instructions. Available at: http://www.ups.com/content/us/en/resources/ship/packaging/guidelines/how_to2.html. Accessed on: 9/18/13.

    Top 4.1.2 General – Storage Access to high quality medical products can be compromised when proper storage is not available or procedures aren’t followed. A strong in-country partner relationship is integral to ensuring that products are stored properly.
      4.1.2.1 Prior to a donation being made recipients should demonstrate that they can provide adequate storage capacity to accommodate necessary supplies and maintenance parts relative to the equipment being donated.

      Guidance: Whether or not the recipient has adequate storage facilities should be identified during the needs assessment process.
      Resources 4.1.2.1 Adequate Storage at Recipient Facility
      Guidelines for the Storage of Essential Medicines and Other Health Commodities Resource Type: Guidelines These guidelines were created by the World Health Organization. They outline how to properly store essential medicines and other health commodities. Some of the sections included are: Receiving and Arranging Commodities; Keeping Track of Products in Your Storeroom; Maintaining the Quality of Your Products; Setting up Your Medical Store, and Waste Management.
      Source: John Snow Institute. The World Health Organization. Guidelines for the Storage of Essential Medicines and Other Health Commodities. Available at: http://deliver.jsi.com/dlvr_content/resources/allpubs/guidelines/GuidStorEsse_Pock.pdf. Accessed on: 9/19/13.
      Storage, Distribution, and Dispensing of Medical Supplies Resource Type: Report These guidelines lay out the proper way to store, distribute, and dispense medical supplies. This is an excellent resource for an MSRO wishing to learn more about proper medical supply storage.
      Source: Belson D. Storage, distribution, and dispensing or medical supplies. Center for Risk and Economic Analysis of Terrorism Events. University of Southern CaliforniaLos Angeles, California. April. 2005. Available at:http://www.usc.edu/dept/create/assets/001/50770.pdf. Accessed on: 9/19/13.

      Top 4.1.3 General – Transportation
          MSROs should consider the following when transporting a donation:
          4.1.3.1 The means is appropriate to the circumstances of the donation. 4.1.3.2 Shipping documents are clear and contain all the essential information. 4.1.3.3 Arrangements for necessary storage are made prior to shipping. 4.1.3.4 The recipient or their designee must be able to provide transportation from the point of entry to the final destination.

          Guidance: MSROs should have an open and ongoing communication process with the recipient regarding transportation throughout the donation process. The MSRO should create and use a transportation checklist for each country and/or recipient to ensure important transportation requirements are not overlooked. In addition, it is often a good idea for an MSRO to work with a freight forwarding company when planning international shipments.
          Resources 4.1.3.1 Transportation Considerations
          How to Plan Your Shipment Resource Type: GuidelinesThis How-to-Guide was created by Missionary Expediters. It explains how to properly plan a shipment for transport. It also provides advice on everything from preparing cargo to choosing a departure port.
          Source: Missionary Expediters. Resources: How To Plan Your Shipment. Available at: http://www.solvenet.com/howto. Accessed on: 9/20/13.
          How to Choose a Freight Forwarder Resource Type: GuidelinesThese guidelines were developed by the Florida District Export Council. They describe how to choose a freight forwarder for international shipping. This is an excellent resource for any MSRO wishing to learn more about selecting and working with freight forwarding companies.
          Source: The Florida Export Council. How to Choose a Freight Forwarder? Available at: http://www.exportflorida.org/exporting/faq-s/124-how-to-choose-a-freight-forwarder. Accessed on: 9/20/13.

          Top 4.1.4 General – Staging and Loading When staging and loading a shipment the following factors should be taken into account:
          4.1.4.1 The mode of transport, product volume and product type.   4.1.4.2 Proper loading should ensure stability (size and weight distribution, strapping), ease and safety of offloading, and be  palletized and shrink wrapped with an accompanying packing list.

          Guidance: This is an important aspect of logistics that is often overlooked. It is important for MSROs to work with the recipient in order to determine the appropriate volume of the donation. While it may seem beneficial and easy to fill a 40ft container for each shipment, if the recipient lacks adequate storage and capacity for the donation, it may cause unintended harm and unnecessary burden on the recipient facility. Before a product is added to a shipment to fill container space, the MSRO needs to ask the recipient if they are able to receive and use the product in question.  It is crucial that all containers are loaded professionally, according to pre-determined practices and procedures, and by experienced staff. It is a good idea for MSROs to develop internal practices regarding the frequency in which items are tied down in the container and the order in which they are loaded. In addition, it may be necessary to pack and load some items in crates, as opposed to only being wrapped. Finally, it is recommended that each pallet be accompanied by it’s own packing list. This will make customs clearance, unloading, and distribution easier for the entire shipment.  
          Resources: 4.1.4.1 Volume Determines Transportation Method
          WHO Procurement and Management of Supplies and Equipment Resource Type: Guidelines This document was created by the WHO and provides information on the proper procurement and management of supplies and equipment. The document provides practical guidelines for all stages of procuring and managing medical supplies and medical equipment. This is an excellent resource for any recipient that wants to learn more about the procurement process and management of medical supplies and equipment.
          Source: The World Health Organization. Procurement and Management of Supplies and Equipment. Available at: http://www.who.int/management/resources/procurement/MedicalSuppliesforPHC(2)Procurement&Management.pdf. Accessed on: 9/16/13.
          Medical Stores Management – Flow and Stock Information Resource Type: Guidelines This document was created by the Management Sciences for Health. It provides information regarding the proper management of inventory and stock flow. This is an excellent resource for a recipient wishing to learn more about proper inventory management and ordering.
          Source: Management Sciences for Health. Management Support Systems: Medical Stores Management. Available at: http://www.msh.org/sites/msh.org/files/mds3-ch44-medicalstores-mar2012.pdf. Accessed on: 9/16/13.
          Container Handbook: Loading and Load Securing Resource Type: Guidelines These guidelines were created by the German Marine Insurers. They are part of a larger Container Handbook. This section addresses areas including packaging and marking, packing and stowage, and load securing. This is an excellent resource for an MSRO that wants to learn how to properly load and secure a container.
          Source: German Marine Insurers. Container Handbook: 4 Loading and Load Securing. Available at:  http://www.containerhandbuch.de/chb_e/stra/index.html?/chb_e/stra/stra_04_00.html. Accessed on: 9/17/13.
          Resources: 4.1.4.2 Proper Loading Procedures
          Guidelines for Working Around Trucks: Loading and Unloading Resource Type: Guidelines These guidelines were produced by the Transport and Storage Industry Sector Standing Committee for Workplace Health and Safety Queensland. It provides important and detailed information on all aspects of the proper loading and unloading of trucks. This is an excellent resource for any MSRO wishing to learn more about proper loading procedures.
          Source: Queensland Government. Department of Education and Industrial Relations. Guidelines for Working Around Trucks: Loading and Unloading. Available at: http://www.deir.qld.gov.au/workplace/resources/pdfs/guidelines-workingaroundtrucks.pdf. Accessed on: 9/16/13
          Container Packing Resource Type: Guidelines These guidelines were put together by Hapag-Lloyd. They outline proper procedures for packing a container. Some of the sections covered include possible stresses during transport, preparing the container for transport, protection against climatic influences, and materials for securing cargo. This is an excellent resource for any MSRO wishing to learn more about how to properly pack a container.
          Source: Hapag-Lloyd. Container Packing. 2010. Available at: http://www.hapag-lloyd.com/downloads/press_and_media/publications/Brochure_Container_Packing_en.pdf. Accessed on: 9/17/13.
          Container Handbook: Loading and Load Securing Resource Type: Guidelines These guidelines were created by the German Marine Insurers. They are part of a larger Container Handbook, This section addresses areas including packaging and marking, packing and stowage, and load securing. This is an excellent resource for an MSRO that wants to learn how to properly load and secure a container.
          Source: German Marine Insurers. Container Handbook: 4 Loading and Load Securing. Available at:  http://www.containerhandbuch.de/chb_e/stra/index.html?/chb_e/stra/stra_04_00.html. Accessed on: 9/17/13.
          Guide to Working with Containers Resource Type: Guidelines This best practice guide was developed by FTA in 2011. It outlines guidelines for working with containers. Subjects included in the document include: dealing with shifting in transit, the risks associated with containers over land, sea and air, and the implications for badly stuffed containers.
          Source: FTA. Working with Containers. 2011. Available at: http://www.fta.co.uk/export/sites/fta/_galleries/downloads/international_supply_chain/working_with_containers.pdf. Accessed on: 9/20/13.

          Top 4.1.5 General – Customs Clearance
            MSROs should confirm that:
            4.1.5.1 MSROs should confirm that the recipient has access to human resources with the capacity to receive the shipment and the necessary clearance documents to move it through customs in a timely manner. 4.1.5.2 Unless otherwise arranged, the recipient must be able to provide transportation from the point of entry to the final destination.

            Guidance: Work with the organization to determine whether or not they have access to the appropriate people to properly receive the shipment. This includes whether or not they will be able to successfully obtain customs clearance documents. Prior to making a shipment, the MSRO should also have written assurance from the recipient that there will be adequate transportation waiting for the shipment upon arrival.
            Resources – 4.1.5.1 General Customs Clearance Procedures
            FDA Export Certificate Guidance Resource Type: Reference This FDA resource has information regarding exportation of vaccines, biologics, and other medical products. It also contains templates and contact information regarding export.
            Source: Food and Drug Administration. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed on 9/5/13.
            FedEx Customs Tools Resource Type: Website This website provides links to various customs tools created by FedEx to assist customers with preparing international shipments. The website provides links to the following tools: FedEx Document Preparation Centre; Regulatory News & Information; FedEx Global Trade Manager; FedEx Electronic Trade Documents; Guide to Customs Forms; international Shipping Resources; Ancillary Clearance Services; Import Shipping and Recipient Information. This is an excellent resource for any MSRO wishing to learn more about proper customs clearance procedures.
            Source: FedEx. Customs Tools. Available at: http://www.fedex.com/ca_english/international/. Accessed on: 9/18/13.
            US Export: Export Licenses, Standards and Economic Sanctions Resource Type: Guidelines, Website This website is hosted by Export.gov. It provides up-to-date information regarding US Exports laws and regulations.
            Source: Export.gov. Export Licenses, Standards, and Economic Sanctions. Available at: http://export.gov/regulation/. Accessed on: 9/20/13.
            Common US Items Generally Restricted for Import in Other Countries Resource Type: Guidelines, Website This website lists items from the United States that are typically restricted for import in other countries.
            Source: MyUS.com. Generally Prohibited and Restricted Items. Available at: http://www.myus.com/en/prohibited-export-import/. Accessed on: 9/20/13.

            Top 4.1.6 General – Security MSROs should ensure that:
              4.1.6.1 It is highly recommended that MSROs use a high security bolt seal that meets C-TPAT and ISO standards.  (ex.) TydenBrooks Intermodal II Seal The seal number should be recorded for internal tracking and on shipping documents.

              Guidance: The MSRO should check to ensure that all shipments comply with international safety standards and requirements.
              Resources – 4.1.6.1 Shipment Security
              Supply Chain Security Best Practices Catalogs, Pamphlet and Addendum Resource Type: Guidelines This document was created by the Customs-Trade Partnership Against Terrorism (C-TPAT) and provides information on maintaining shipment security in the supply chain. One section of the document discusses container seals. This information would help helpful for an MSRO wishing to learn more about international shipment security.C-TPAT Best Practices Catalog Addendum 2009C-TPATBest Practices Pamphlet 2009Customs-Trade Partnership Against Terrorism (C-TPAT). Supply Chain Security Best Practices Catalog.
              Source: U.S. Customs and Border Protection. Customs-Trade Partnership Against Terrorism (C-TPAT). Supply Chain Security Best Practices Catalog. Available at: http://www.cbp.gov/border-security/ports-entry/cargo-security/c-tpat-customs-trade-partnership-against-terrorism/bestpractices. Accessed on: 9/16/13.
              TydenBrooks: Information on Bolt Seals Resource Type: Website This website provides information on the different Bolt Seals produced by TydenBrooks. This is an excellent resource for any MSRO wishing to learn more about different security seal options for international shipments.
              Source: TydenBrooks. Bolt Seals: How They Keep the World Held Together. Available at:  http://www.tydenbrooks.com/Newsroom/Articles/Transportation-Cargo/Bolt-Seals-How-they-keep-the-world-held-together.aspx. Accessed on: 9/16/13.
              Customs Trade Partnership Against Terrorism: Security Seal Standards for C-TPAT Resource Type: This document describes the C-TPAT Security Seal Standards. This is an excellent resource for any MSRO wishing to learn more about international shipping security standards.
              Source: Stoffel. Customs Trade Partnership Against Terrorism. Security Seal Standards for C-TPAT. Available at: http://www.stoffel.com/files/whatisctpat.pdf. Accessed on: 9/16/13.

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              4.2 Logistics – Consumables

              4.2.1 Consumables – Packaging MSROs should ensure that:
              4.2.1.1 Expiry date should be clearly labeled on all packaging. 4.2.1.2 Consumables are packed in boxes that protect the integrity of the product and are suitable for transportation. 4.2.1.3 Packaging should be sealed securely to prevent opening in transit and tampering.

              Guidance: Consumables should be packaged in boxes that are appropriate for the size and type of product. The smallest box possible should always be used, to avoid having empty space that might endanger the integrity of the package. All boxes should be properly sealed and secured within the container.
              Resources: Consumables – Packaging
              Packaging for Medical Devices and Pharmaceuticals Resource Type: Article This article discusses protective packaging for medical devices and pharmaceuticals.
              Citation: Enright, Cicely. Packaging for Medical Devices and Pharmaceuticals. 2009. ASTM International, Standardization News. Available at:   http://www.astm.org/SNEWS/SO_2009/enright2_so09.html. Accessed on: 9/3/13. 
              UPS: How to Prepare for Shipping Resource Type: Guidelines This website was created by UPS and provides guidelines for properly packaging a shipment. The guidelines include information on providing proper internal protection, as well as, proper labeling.
              Source: UPS. How to Prepare for Shipping: Step-by-Step Instructions. Available at: http://www.ups.com/content/us/en/resources/ship/packaging/guidelines/how_to2.html. Accessed on: 9/18/13.

              Top   4.2.2 Consumables – Storage MSROs should determine that:
              4.2.2.1 Recipients can demonstrate that they can provide adequate storage capacity to accommodate the donated consumables prior to shipping.

              Guidance: The Needs Assessment should include storage capacity. Part of this process should be a discussion of whether or not the recipient has adequate storage facilities for the product being donated.
              Resources: 4.2.2.1 – Adequate Consumable Storage Capacity at Recipient Site
              Guidelines for the Storage of Essential Medicines and Other Health Commodities Resource Type: Guidelines These guidelines were created by the World Health Organization. They outline how to properly store essential medicines and other health commodities. Some of the sections included are: Receiving and Arranging Commodities; Keeping Track of Products in Your Storeroom; Maintaining the Quality of Your Products; Setting up Your Medical Store, and Waste Management.
              Source: John Snow Institute. The World Health Organization. Guidelines for the Storage of Essential Medicines and Other Health Commodities. Available at: http://deliver.jsi.com/dlvr_content/resources/allpubs/guidelines/GuidStorEsse_Pock.pdf. Accessed on: 9/19/13.
              Solving storage challenges in the Amhara region Resource Type: Case Study This case study provides an example of a recipient warehouse that was improved by reorganizing their storage facility.
              Source: John Snow Inc. JSI Research and Training Institute. Case Study: Solving storage challenges in the Amhara region. Accessed on: http://www.jsi.com/JSIInternet/Features/article/display.cfm?thisSection=Features&thisSectionTitle=Features&thisPage=stories&ctid=na&cid=na&tid=20&id=297. Accessed on 9/20/13.

              Top 4.2.3 Consumables – Transportation MSROs should ensure that:
              4.2.3.1 The means of transportation is appropriate to the circumstances of the donation. 4.2.3.2 Shipping documents are clear and that they contain all the necessary information. 4. 2.3.3 All consumables are palletized and shrink wrapped with an accompanying packing list.  

              Guidance: MSROs should have an open and ongoing communication process with the recipient regarding transportation throughout the donation process. The MSRO should create and use a transportation checklist for each country and/or recipient to ensure important transportation requirements are not overlooked. In addition, it is often a good idea for an MSRO to work with a freight forwarding when planning international shipments.
              Resources: 4.2.3.1 – Consumable Transportation Logistics
              Sample Packing List Resource Type: Template This is a sample packing list created by KKFreight. It provides an excellent example of packing lists that should accompany a shipment.
              Source: KKFreight. Sample Packing List. Available at: http://www.kkfreight.com/documents/packlist.pdf. Accessed on: 9/19/13.
              How to Choose a Freight Forwarder Resource Type: Guidelines These guidelines were developed by the Florida District Export Council. The describes how to choose a freight forwarder for international shipping. This is an excellent resource for any MSRO wishing to learn more about selecting and working with freight forwarding companies.
              Source: The Florida Export Council. How to Choose a Freight Forwarder? Available at: http://www.exportflorida.org/exporting/faq-s/124-how-to-choose-a-freight-forwarder. Accessed on: 9/20/13.
              How to Plan Your Shipment Resource Type: Guidelines This How-to-Guide was created by Missionary Expediters. It explains how to properly plan a shipment for transport. It provides advice on everything from preparing cargo to choosing a departure port.
              Source: Missionary Expediters. Resources: How To Plan Your Shipment. Available at: http://www.solvenet.com/howto. Accessed on: 9/20/13.

              Top 4.2.4 Consumables – Staging and Loading
                When staging and loading a shipment of consumables the following factors should be taken into account:
                4.2.4.1  The mode of transport, product volume and product type.   4.2.4.2 Proper loading should ensure stability (size and weight distribution, strapping), ease and safety of offloading, and be  palletized and shrink wrapped with an accompanying packing list.

                Guidance: Volume is an important aspect of logistics that is often overlooked. It is important for MSROs to work with the recipient in order to determine the appropriate volume of the donation. While it may seem beneficial and easy to fill a 40ft container for each shipment, if the recipient lacks adequate storage and capacity for the donation, it may cause unintended harm and unnecessary burden on the recipient facility. Before a product is added to a shipment to fill container space, the MSRO needs to ask the recipient if they are able to receive and use the product in question. When loading, it is crucial that all containers are loaded professionally, according to pre-determined practices and procedures, and by experienced staff. It is a good idea for MSROs to develop internal practices regarding the frequency in which items are tied down in the container and the order in which they are loaded. In addition, it may be necessary to pack and load some items in crates, as opposed to only being wrapped. Finally, it is recommended that each pallet be accompanied by it’s own packing list. This will make customs clearance, unloading, and distribution easier for the entire shipment.
                Resources: 4.2.4.1 – Staging and Loading of Consumables
                Guidelines for Working Around Trucks: Loading and Unloading Resource Type: Guidelines These guidelines were produced by the Transport and Storage Industry Sector Standing Committee for Workplace Health and Safety Queensland. it provides important and detailed information on all aspects of the proper loading and unloading of trucks. this is an excellent resource for any MSRO wishing to learn more about proper loading procedures.
                Source: Queensland Government. Department of Education and Industrial Relations. Guidelines for Working Around Trucks: Loading and Unloading. Available at: http://www.deir.qld.gov.au/workplace/resources/pdfs/guidelines-workingaroundtrucks.pdf. Accessed on: 9/16/13
                Container Packing Resource Type: Guidelines These guidelines were put together by Hapag-Lloyd. They outline proper procedures for packing a container. Some of the sections covered include possible stresses during transport, preparing the container for transport, protection against climatic influences, and materials for securing cargo. This is an excellent resource for any MSRO wishing to learn more about how to properly pack a container.
                Source: Hapag-Lloyd. Container Packing. 2010. Available at: http://www.hapag-lloyd.com/downloads/press_and_media/publications/Brochure_Container_Packing_en.pdf. Accessed on: 9/17/13.
                Container Handbook: Loading and Load Securing Resource Type: Guidelines These guidelines were created by the German Marine Insurers. They are part of a larger Container Handbook. This section addresses areas including packaging and marking, packing and stowage, and load securing. This is an excellent resource for an MSRO that wants to learn how to properly load and secure a container.
                Source: German Marine Insurers. Container Handbook: 4 Loading and Load Securing. Available at:  http://www.containerhandbuch.de/chb_e/stra/index.html?/chb_e/stra/stra_04_00.html. Accessed on: 9/17/13.

                Top 4.2.5 Consumables – Customs Clearance
                  MSROs should ensure that:
                  4.2.5.1 That recipients have access to human resources with the capacity to receive the shipment and the necessary clearance documents to move it through customs in a timely manner. 4.2.5.2 The recipient must be able to provide transportation from the point of entry to the final destination.

                  Guidance: Having a trusted in-country partner or expert on staff is integral to successful customs clearance, as well as, ensuring the donation arrives at the final destination safely.
                  Resources: 4.2.5.1 – Consumables Customs Clearance
                  FedEx Customs Tools Resource Type: Website This website provides links to various customs tools created by FedEx to assist customers with preparing international shipments. The website provides links to the following tools: FedEx Document Preparation Centre; Regulatory News & Information; FedEx Global Trade Manager; FedEx Electronic Trade Documents; Guide to Customs Forms; International Shipping Resources; Ancillary Clearance Services; Import Shipping and Recipient Information. This is an excellent resource for any MSRO wishing to learn more about proper customs clearance procedures.
                  Source: FedEx. Customs Tools. Available at: http://www.fedex.com/ca_english/international/. Accessed on: 9/18/13.
                  FDA Export Certificate Guidance Resource Type: Reference This FDA resource has information regarding exportation of vaccines, biologics, and other medical products. It also contains templates and contact information regarding export.
                  Source: Food and Drug Administration. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. Accessed on 9/5/13.
                  Mission Possible – Customs Clearance Resource Type: Video This video provides a general overview and helpful checklist for customs clearance documentation.
                  Source: The Partnership for Quality Medical Donations.

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                  4.3 Logistics – Medical Equipment

                  4.3.1 Medical Equipment – Packaging 
                    MSROs will ensure that:
                    4.3.1.1 The equipment is crated and/or packed to minimize damage during shipment. 4.3.1.2 The necessary components referred to in the installation instructions are included, packaged together and shipped with the equipment. 4.3.1.3 Installation (for equipment that requires installation), operating and maintenance instructions are included for all equipment. If the instructions are not available, the MSRO will work with the recipient to confirm that they have the capacity to appropriately use the donation.

                    Guidance: When packaging and shipping medical equipment, the MSRO needs to work closely with the recipient. There should be open communication regarding package size and composition, to ensure that the recipient will be able to unload the equipment upon arrival. In addition, prior to shipping a piece of equipment the MSRO needs to understand the recipient’s capacity to properly install the item. The MSRO needs to make sure all necessary manuals and instructions are included that the recipient will require for installation.
                    Resources: 4.3.1.1 – Proper Medical Equipment Packaging Procedures
                    Worldwide Medical Device Guidelines Resource Type: Website This website provides important information regarding medical device guidelines in different countries. The homepage has a list of countries, and when the user clicks on a particular country, they are takes to a page with guidelines relating to the country selected.
                    Citation: Emergo Group. Worldwide Medical Device Regulations. Available at: http://www.emergogroup.com/resources/worldwide-medical-device-regulations. Accessed on: 9/3/13. 
                    Medical Device Regulatory Process Charts and Approval Timelines Resource Type: Website This resource provides helpful information for various countries of the world and is a helpful resource when looking for device regulatory information.
                    Citation: Emergo Group. Free Medical Device Regulatory Process Charts and Approval Timelines. Regulatory Charts and Approval Timelines. Available at: http://www.emergogroup.com/resources/regulatory-process-charts. Accessed on: 9/3/13. 

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                    4.4 Logistics – Pharmaceuticals

                    4.4.1 Pharmaceuticals – Packaging
                      When packaging pharmaceuticals for donation, MSROs should take into account the following factors:
                      4.4.1.1 The climatic conditions in the recipient country. 4.4.1.2 The necessary steps are taken and materials used to avoid breakage. 4.4.1.3 That products requiring maintenance of cold-chain must be properly labeled and contain control thermometers. 4.4.1.4 That shipping documents include the product’s generic name, along with other relevant information, e.g., quantity, expiration date, lot and control numbers and storage/temperature requirements. 4.4.1.5 That prescribing information is in a language that will be understood by a staff member at the recipient institution.

                      Guidance: MSROs should confirm pharmaceuticals will arrive at the recipient with at least 6-10 months left before expiry. Recipients should be informed of expiry dating and agree to taking the product, prior to any pharmaceutical being shipped.
                      Resources:  4.4.1.1 Proper Pharmaceutical Packaging
                      Standard Medical Equipment Labeling and Packaging Resource Type: Reference This resource includes common symbols used in medical equipment labeling. This includes symbols for sterilization, units, instruction, cleaning, maintenance, environmental, technical description, transport, storage, and collateral information.
                      Source: MD+DI, Available at: http://www.mddionline.com/article/iec-60601-1-medical-device-marking-and-labeling. Accessed on 9/5/13.
                      Vaccine Cold Chain Guidelines Resource Type: Guidelines These guidelines outline what is involved in a proper cold chain process. In addition, information is provided on monitoring the shipment to ensure that cold chain was properly maintained.
                      Source: Australian Department of Health. Vaccine Cold Chain Guidelines. Available at: http://www.health.wa.gov.au/CircularsNew/attachments/623.pdf. Accessed on: 9/18/13.

                      Top 4.4.2 Pharmaceuticals – Transportation MSROs should ensure that:
                        4.4.2.1 When shipping pharmaceuticals MSROs should use only qualified, licensed, and reliable transport companies. 4.2.2.2 The duration of time that a shipment will spend in transport should be taken into account when considering the appropriate means of transportation for items requiring refrigeration.

                        Guidance: When determining the proper transportation method for pharmaceuticals, the MSRO needs to carefully consider the item’s expiry date and storage temperature requirements. For example, if a particular vaccine being shipped requires the maintenance of cold chain, the MSRO must choose an appropriate mode of transportation.  
                        Resources:  4.4.2.1 Proper Transportation of Pharmaceuticals
                        Handbook for Vaccine & Cold Chain Handlers Resource Type: PDF This resource provides excellent information about the cold chain system and cold chain equipment.Source: UNICEF. Handbook for Vaccine & Cold Chain Handlers. Available at: http://www.unicef.org/india/Cold_chain_book_Final_(Corrected19-04-10).pdf. Accessed on: 9/3/13. 
                        USAID Cold Chain and Logistics Management Resource Type: NewsletterCitation United States Agency for International Development. Immunization Basics Snap Shots. Cold Chain and Logistics Management: An Essential Part of Safe and Effective Vaccination Programs. Available at: http://www.immunizationbasics.jsi.com/Newsletter/Archives/snapshots_volume8.htm. Accessed on: 9/3/13. 
                        WHO Good Distribution Practices for Pharmaceutical Products Resource Type: Guidelines This document was created by the World Health Organization and outlines good distribution practices for pharmaceutical products. Some of the sections in this document address warehousing and storage, vehicles, equipment, and transportation and products in transit.
                        Source: The World Health Organization. WHO Technical Report Series: WHO Good Distribution Practices for Pharmaceutical Products. Available at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistributionPracticesTRS957Annex5.pdf. Accessed on: 9/16/13.
                        Cold-Chain Management and the Use of TempTale Technology Resource Type: Article This article describes how to properly use a TempTale to determine if cold chain has been properly maintained.
                        Source: Colonel Mitchell E. Brew, Major Michael Ronn, and Petty Officer First Class Summer Webb, USN. Cold-Chain Management and the Use of TempTale Technology. Army Sustainment. PB 700-10-05 Volume 42, Issue 5. Available at: http://www.almc.army.mil/alog/issues/SepOct10/coldchain_mgmt.html. Accessed on: 9/20/13.
                        Key Performance Indicators in Humanitarian Logistics Resource Type: Academic Resource This resource provides input on its findings that identify key performance indicators of high quality humanitarian logistics. It uses a “scorecard” to evaluate logistics procedures and identifies improvement strategy.
                        Source; The Fritz Institute, Anne Leslie Davidson 2006. Available at: http://www.fritzinstitute.org/PDFs/findings/XS_Davidson_Anne.pdf. Accessed on 9/20/13.
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