TRAINEE - World Health Organization

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TRAINEES Chapter 4 • GLP Training Manual
very important. The sponsor should consider the method of transport used and the
duration of the journey. This is particularly true when the material is packed in fragile
containers, such as glass bottles, or needs to be transported long distances using public
transport under special conditions, e.g. kept frozen. Consideration should always be
given to the unexpected such as airport delays, strikes or bad weather.
The test item should be accompanied by a delivery form detailing:
– Manufacturer’s name or sponsor’s name.
– Date of despatch.
– Number of containers or items, type, amount of contents.
– Identity of test item.
– Batch number(s).
– Identity of person responsible for despatch.
– Name of carrier.
Each test material container should be clearly labelled with sufficient information to
identify it and allow the testing facility to confirm its contents. Ideally, labels should
contain the following information:
– Test item name.
– Batch number.
– Expiry date.
– Storage conditions.
– Container number.
– Tare weight.
– Initial gross weight.
On arrival of the test item, the testing facility should have a procedure for handling
and documentation of receipt. It is most important that the compound is logged in
immediately to ensure a complete audit trail and to demonstrate that it has not been
held under conditions which might compromise its chemical activity. The receipt procedure
should include instructions for handling if designated person is absent or if the
container is damaged on receipt. The study director should be informed of the arrival
of the test item.
A test facility’s documentation, on arrival of the test item, normally includes the following
information:
– Compound name.
– Batch number(s).