Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario. We are continuing with our no deal planning to ensure we are fully prepared.
If the UK leaves the EU without a deal, supply chains for products sourced from the European Union and European Economic Area (EEA) may be affected by changes to border processes and procedures. At the request of the Department of Health and Social Care (DHSC), pharmaceutical companies have been contingency planning to ensure continuity of supply. These measures include building stockpiles and using air freight to avoid any border delays.
The shipment of medicines by air freight requires specific control measures. This guidance provides advice on Good Distribution Practice (GDP) requirements for air freight to ensure that product quality and security is protected.
1. Introduction to air transport
This guidance refers to extracts from the World Health Organization (WHO) technical series 961 and WHO Supplement 12: Temperature-controlled transport operations by road and by air to outline transportation factors specific to air freight of medicines. These extracts are provided as indented text. It should be read and implemented in conjunction with EU Good Distribution Practice (GDP) guidance.
The International Air Transport Association’s Perishable Cargo Regulations and Temperature Control Regulations is the industry’s framework for meeting GDP. The purpose of the regulations include:
- Recommend Critical Control Points to reduce these risks
- Define labelling requirements
- Recommend handling procedures
Many air carriers offer ‘branded services’ with defined procedures based on GDP to meet the specific needs of pharmaceuticals. Any variation or deviation from such a branded service should be defined and negotiated beforehand in a specific SOP.
In order to minimise risk, shippers should always collaborate with the air carrier, either directly or through the designated freight forwarding agent. It is essential to do this in order to define and agree the service level needed to meet the shipper’s requirements.
Temperature control within the cargo holds of most aircraft is limited and wide variations can occur throughout the hold; these variations depend upon placement, location, time at altitude, and the duration of the flight. However, the greatest and most frequent vulnerability to temperature exposure occurs on the airport tarmac when goods are exposed to the elements before aircraft loading, or during unloading. Every precaution should be made to limit this exposure. Shippers are encouraged to work with their air service suppliers to minimise tarmac times
2. GDP Principles of transportation
EU GDP chapter 9 requires that medicinal products are protected against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.
A safe and reliable temperature-controlled transport operation starts with a comprehensive User Requirements Specification, informed by a thorough risk assessment exercise. This can be used as a basis for contracting out services via a contract or Technical Agreement, or for managing an in-house operation. However the service is provided, suitable SOPs, standard check lists and associated work instructions must be developed and used to control each shipment.
The GDP responsibilities between all parties involved in the supply chain should be clearly defined as set out in chapter 7 of the GDP guidelines.
3. Risk control measure
Transportation requirements are outlined in section 9.2 of the GDP guidelines. Specific risk control measures proposed by WHO for air transportation of medicines include:
3.1 Product preparation and conditioning at shipper’s location
- Use defined conditioning and staging time specifications for packaging components (temperature and duration), compliant with Design Qualification and Operational Qualification of the shipment container used.
3.2 Product loading at shipper’s location
- Use a defined loading process, with check sheet
- Application of IATA TTSPP label
- Define actions to take in the event of delays
3.3 Ground transport from shipper location
- Use a refrigerated or temperature-controlled vehicle. This should be pre-conditioned to a defined temperature before loading. Electronic temperature monitoring should be used.
- Ensure that equipment has been serviced and checked as required
3.4 Warehousing (en route)
- Use of International Air Transport Association (IATA) ‘Standard Acceptance Checklist for Time and Temperature Sensitive Healthcare Shipment‘
- Temperature monitoring of the warehouse.
- Availability of batteries, electrical connections or dry ice to maintain correct temperature of active containers
- Availability of sub-zero, refrigerated or controlled room temperature storage when required
- Ensure defined storage instructions are available
- Specify actions to take in the event of delays, and mishaps en route
3.5 Airport tarmac/apron
- Minimise the time product is exposed to ambient temperatures
- Use of high priority ramp handling
- Use of covered storage when transiting through multiple airports
- Use of passive protection tools such as thermal blankets
- Specify actions to take in the event of delays
3.6 Aircraft hold
- Avoid positioning near cargo door
- Cargo hold temperatures should be maintained between +15.0°C and +25.0°C
- NOTOC (notification to captain) defining cargo hold temperature setting or use of dry ice in active containers
4. Air cargo security checks
The additional security checks required for air cargo should be considered in supply chain logistics. All cargo must be physically screened if classified as ‘not secured’. This may lead to additional delays in shipment, or time out of controlled storage conditions.
Alternatively, consignments may come from a secure supply chain (the supplying company certified as a ‘known consignor’) before being loaded onto an aircraft.
The effect of aircraft hold pressure on container integrity should be considered, particularly for sterile products. These risks may be addressed through validation studies at low pressure, or by ensuring that the aircraft hold is pressurised at altitude.
5. Containers, packaging and labelling
Containers, packaging and labelling requirements are outlined in section 9.3 of the GDP Guidelines. Specific measures for air transport include:
5.1 Air transport labelling
Since July 2012, the IATA Time and Temperature Sensitive label, has been mandatory for the transport of healthcare cargo shipments. There are specific conditions for proper use of the label. These can be found in the current edition of the IATA Perishable Cargo Regulations, Chapter 17: Logistics for Temperature Sensitive Healthcare Products.
5.2 Correct use of labelling
The principal rules for the correct use of the label are as follows:
- Shipments must be booked under the proper handling code and as temperature-controlled healthcare cargo in accordance with the IATA Perishable Cargo Regulations
- The label must be used for healthcare products only.
- The label may be applied to both active and passive shipping systems.
- The lower half of the label must indicate the external handling temperature range or limit (minimum and maximum) that the package can be exposed to during transport.
- The label must be attached to a consignment which has been specifically booked as a time and temperature-sensitive healthcare product.
- The temperature range on the label must match the temperature range or limit stated on the Air Waybill, Service Level Agreement or Standard Operating Procedure
- The text must be in English and temperatures must be shown in degrees Celsius.
- The label must be applied by the shipper or by his designated agent.
- Only one label is required. This must be visible on the outermost means of containment (box, over-pack, or Unit Load Device).
6. Medicines regarding special conditions
Section 9.3 of the GDP Guidelines outlines the handling of products requiring special conditions. Further advice on qualifying new equipment used for air transport can also be found in Supplement 13: Qualification of shipping containers.