Pharmaceutical
Basic terminology.
Pharmaceuticals
Vaccines
Biologicals
Certain biotechnologies
Pharmaceuticals
Biotech Products
It is the responsibility of the shipper to ensure that the product is packed correctly for transportation. It is preferred that temperature monitoring devices accompany the cargo. This should be provided upon packaging.
Labelling &
Documentation.
Regulatory agencies require that healthcare products be labelled to define the acceptable storage temperature and instructions.
It is the responsibility of the drug product manufacturer to define the acceptable temperature range of the product.
When a specific temperature range is indicated on the Time and Temperature Sensitive label (example below), the temperature range always reflects the handling (external) temperature allowed during transportation and distribution and not the actual product (internal) temperature.
The Time and Temperature Sensitive label must be affixed to at least 1 side panel of the outermost visible means of containment.
When agreed, the lower half of the label may also be used to communicate SOP numbers in addition to the temperature range.
No other handling information may be indicated on the label.
Mandatory IATA Time & Temperature Sensitive label, effective 1st July 2012:
OPERATIONS
Procedures.
On arrival of cargo at Morgan Cargo's warehouse, the following procedures will be followed:
01
On arrival of cargo, weight, dimensions & number of pieces will be noted & checked against the packing list or import bookings list. Any discrepancies will be noted on the goods received delivery sheet. At point of entry the commodity is established and dealt with accordingly.
02
Arrival temperatures will be taken & the product to be placed either in a suitable segregated cold room or other suitable segregated storage area, according to the temperature range as indicated by the supplier. Regular temperature checks will need to be conducted (can be through use of temperature recorder).
03
Shipments should be stored off the ground, racks and pallets should be well maintained and kept in good state of cleanliness.
04
All cargo will be handled according to the latest IATA rules and regulations of the specific commodity.
DISTRIBUTION
Shipment.
Upon request a truck (depending on the size of the shipment and temperature range indicated by the supplier) may be dispatched for collection or delivery.
Co-loading with general, non-temperature sensitive cargo, should be avoided in order to ensure no temperature deviations during transit.
