All operations performed, including the controls, should be documented in detail step by step at the time
each action is taken. The persons performing each task should be clearly identified (operators and
controllers). All precautions taken to avoid mix-ups should be documented in the batch records. Batch
records should include at least the following information:
line clearance before the start of the packaging operations, and between the packaging of
different products;
date and time the packaging operation is started and completed, for each product;
identity of the product packaged, including the batch number, expiry date and a physical
description of the product;
type of container used for packaging, including the closing/stopping material;
numbers of the subjects for whom the product is prepared, or precise reference to the
randomisation list followed (reference number, seed used to generate the list). In such a case a
copy of the randomisation list, which should be dated and signed when edited, should be attached
to the batch record;
number of IMP units dispensed per container;
if the IMP was provided to the CRO packaged under blister strip, whether the IMP was removed
from the blister or whether the blister was cut and the IMP dispensed while still in a piece of
blister strip;
in the case of a liquid formulation, how the product was reconstituted if applicable, material used
to measure the volume dispensed/packaged into each container; and expiry date of the finished
product if applicable.
number of IMP units, containers and labels introduced in the working area, used and remaining
(reconciliation);
mention of any special problem or unusual events, and signed authorisation for any deviation from
the instructions;
release of the packaged products after all checks and controls are completed (authorisation to use
the products for the trial after all necessary verifications have been performed and the necessary
documentation has been completed).
Copies of the labels, showing they have been checked against the randomisation list and approved,
should be appended to the batch records.
All controls performed, and the identity of the person(s) performing each control, should be documented
with the signature of the individual in charge.
As the test and reference product are to be packaged separately the use of separate batch records per
product is strongly encouraged. If IMP are to be packaged/dispensed during separate operations for each
trial period, separate batch records should be kept for each period.
