Checklist for Implementation of GDP Principles - Part 9: Transportation

According to Chapter 9 (Transportation) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) "it is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be utilised when planning transportation."

Checklist: Implementation of GDP Principles at Wholesale Distributors

The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 9 of the 2013 guidelines:

Vehicles and equipment

• Required storage conditions are maintained during transportation
• Vehicles and equipment are suitable and appropriately equipped to prevent exposure of the products to conditions that could affect their quality and packaging integrity, and to prevent contamination of any kind
• Procedures are in place for the operation and maintenance of all vehicles and equipment, including cleaning and safety precautions
• Validated temperature control systems (e.g. thermal packaging, temperature controlled containers, and refrigerated vehicles) are used to ensure correct transport conditions
• If refrigerated vehicles are used temperature mapping is performed under representative conditions including seasonal variations
• Equipment used for temperature monitoring during transport within vehicles and/or containers, is maintained and calibrated at regular intervals at least once a year
• Risk assessment of delivery routes has been performed to ensure appropriate temperature controls are in place for
  - Inbound product
  - Outbound product
     E.g. review of live temperature records, dummy sample deliveries
• If coolpacks are used in insulated boxes, they are located such that the product does not come in direct contact with the coolpack
• If coolpacks are used in insulated boxes, staff are trained on the procedures for assembly of the insulated boxes (seasonal configurations) and on the reuse of coolpacks.
• The process for delivery of sensitive products and control of seasonal temperature variations is described in written procedures
• Procedures cover management of unexpected occurrences such as vehicle breakdown or nondelivery
• A procedure is in place for investigating and handling temperature excursions
• Where nondedicated vehicles and equipment are used procedures are in place to ensure that the quality of the medicinal product will not be compromised

Delivery

• Delivery drivers (including contract drivers) are trained in the relevant areas of GDP
• Deliveries are made directly to the address stated on the delivery note
• Deliveries are handed into the care of the consignee
• Deliveries are not left on alternative premises
• Procedures are in place for out of hours/unscheduled deliveries with responsibilities stated for specified persons

Transportation hubs

• When using transportation hubs, the time limit for storage in these locations is defined
• When using transportation hubs, premises are audited and approved prior to deployment
• A minimum specification for transport hubs is available
• A list of Hubs used by the transportation company is available

Deviations

• Deviations are reported to the distributor and recipient
• Where necessary in the case of deviations, the manufacturer of the medicinal product is contacted for information about appropriate steps to be taken

Containers, packaging and labeling

• Container and packaging is selected based on:
  - the storage and transportation requirements
  - the space required for the amount of medicines
  - the anticipated external temperature extremes
  - the estimated maximum time for transportation including transit storage at customs
  - the validation status of the packaging and shipment containers
• The containers in which medicinal products are shipped are sealed
• A document is enclosed to ascertain the following:
  - date
  - name and pharmaceutical form of the medicinal product
  - batch number at least for products bearing the safety features, where required
  - quantity supplied
  -  name and address of the supplier
  -  name and delivery address of the consignee (actual physical storage premises, if different)
  -  applicable transport and storage conditions
• Containers bear labels providing sufficient information on handling and storage requirements and precautions
• Containers bear labels enable identification

Transportation of Products requiring special Conditions

• Requirements laid down by the concerned Member States are met
• Additional control systems in place e.g. for
  - Special Containers
  - Picking/Packing/Packaging of goods
  - Training on procedures for assembly of insulating boxes (passive / active)
  - Conditioning and reuse of cool packs with segregation of frozen and chilled ice packs
• Transportation is performed in safe, dedicated and secure containers and vehicles

Reference

The points listed above are an excerpt from the "ECA Roadmap to Good Distribution Practice (GDP)", which includes checklists to verify the minimum implementation of GDP, based on the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). The European GDP Association (GDPA) has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. The PDF is available for download free of charge in the GDPA members' area.