The new Good Distribution Practice guidelines are
now in effect. All requirements relative to distributing medicinal products
under controlled temperature have been reinforced.
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
the official document
Chapter 3: The basics to remember regarding premises
- 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
- Maintain temperature
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
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.
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.
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
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.