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The cold chain within GDP

25 February 2014

The new Good Distribution Practice guidelines are now in effect. All requirements relative to distributing medicinal products under controlled temperature have been reinforced.

All requirements relative to distributing medicinal products under controlled temperature have been reinforced.

While some rules already exist (temperature control, device calibration, use of appropriate equipment for transporting heat-sensitive medicinal products), two chapters are now dedicated to equipment and storage/transport conditions for medicinal products under controlled temperature! We have summarized their contents for you. 

> Consult the official document

Chapter 3: The basics to remember regarding premises and equipment

  •  Adapt and maintain premises in order to provide proper storage and safety conditions. All aspects of operations can then be successfully performed, in full compliance with temperature, hygiene conditions, etc.

  • Control the storage environment using an appropriate set of instruments and procedures, along with a temperature map derived from the risk analysis.

  • Design and maintain equipment to ensure suitability for its intended use. Install and calibrate appropriate alarms and control devices to notify operators in case of deviations.

  • Certify and validate all critical equipment after any major change, with reliance on reports summarizing results (cold storage rooms, alarms, recording systems, etc.). Proceed as necessary with all corrective and preventive measures (CAPA).

Chapter 9: Transport in an insulated or a refrigerated packaging

Maintaining the temperature during the transport in a temperature-controlled packaging.

  • Maintain temperature within acceptable limits: plan transport based on the corresponding risk analysis, note all deviations, monitor temperature in the refrigerated vehicles whenever applicable, draw up a temperature map under representative conditions.

  • Adopt appropriate procedures relative to the use and maintenance of all vehicles and equipment involved in distribution: assess the risks associated with delivery itineraries in order to determine the points requiring temperature controls, calibrate temperature monitoring instruments at regular intervals and at least once a year.

  • Inform haulers of the transport and storage conditions: limit the amount of time spent in temporary storage; and ensure constant temperature, cleanliness and safety of products.

  • Select the appropriate insulated or cooling packaging solution on the basis of requirements for storing and transporting medicinal products or heat-sensitive products: minimum amount of space, anticipated temperature peaks, maximum estimated distribution time (including temporary holding while clearing customs). The selected containers must be both certified and valid. An appropriate label must also be affixed to all containers.

  • Train staff in applicable procedures (seasonal configurations) and in the competent repair and use of gel packs, which must not be placed in direct contact with products inside the insulated shipping system.

  • Draft procedures regarding the delivery of sensitive products and the process for controlling seasonal temperature variations.

Sofrigam is contributing to the effective management of your cold chain transport logistics by proposing the design and qualification of customized insulated packaging, along with a complete set of logistics services.

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