Guidance

Guidance on air freight of medicines

Updated 9 October 2019

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 product quality and security.

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. You should be read and implement this together 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:

• recommending critical control points to reduce risks
• defining labelling requirements
• recommending 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 standard operating procedure (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 in the cargo holds of most aircraft is limited and wide variations can occur throughout the hold. These variations depend on 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. You should make every precaution to limit this exposure: work with your 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. You can use this 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, you must develop suitable SOPs, standard check lists and associated work instructions, and use them 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 measures

Transportation requirements are outlined in section 9.2 of the GDP guidelines. Specific risk control measures proposed by the WHO for air transportation of medicines include the following points.

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

You should:

• use a defined loading process, with check sheet
• apply IATA TTSPP label
• define actions to take if there are delays

3.3 Ground transport from shipper location

You should:

• use a refrigerated or temperature-controlled vehicle that is pre-conditioned to a defined temperature before loading
• use electronic temperature monitoring
• ensure that equipment has been serviced and checked as required

3.4 Warehousing (en route)

You should:

• use International Air Transport Association (IATA) standard acceptance checklist for time and temperature sensitive healthcare shipment
• monitor the warehouse temperature
• ensure availability of batteries, electrical connections or dry ice to maintain correct temperature of active containers
• ensure availability of sub-zero, refrigerated or controlled room temperature storage when required
• ensure defined storage instructions are available
• specify actions to take in case of delays and mishaps en route

3.5 Airport tarmac/apron

You should:

• minimise the time product is exposed to ambient temperatures
• use high priority ramp handling
• use covered storage when transiting through multiple airports
• use passive protection tools such as thermal blankets
• specify actions to take in case of delays

3.6 Aircraft hold

You should:

• avoid positioning near cargo door
• maintain cargo hold temperatures between +15.0°C and +25.0°C
• use NOTOC (notification to captain) defining cargo hold temperature setting or use of dry ice in active containers

4. Air cargo security checks

You should consider the additional security checks required for air cargo 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.

You should consider the effect of aircraft hold pressure on container integrity, particularly for sterile products. Reduce these risks 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 available 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 that:

• 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 that 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 their designated agent
• only 1 label is required, it 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 is available in Supplement 13: Qualification of shipping containers.