Monitoring of storage conditions
Recorded temperature monitoring data should be available for review. The
equipment used for monitoring should be checked at suitable
predetermined intervals and the results of such checks should be recorded
and retained. All monitoring records should be kept for at least the shelf-life
of the stored material or product plus 1 year, or as required by national
legislation. Temperature mapping should show uniformity of the
temperature across the storage facility. It is recommended that
temperature monitors be located in areas that are
most likely to show fluctuations.
Equipment used for monitoring should also be calibrated at defined intervals.
Storage requirements
Documentation: written instructions and records
Written instructions and records should be available which document all
activities in the storage areas including the handling of expired stock.
These should adequately describe the storage procedures and define the
route of materials and pharmaceutical products and information through
the organization in the event of a product recall being required.
Permanent information, written or electronic, should exist for each stored
material or product indicating recommended storage conditions, any
precautions to be observed and retest dates. Pharmacopoeial
requirements and current national regulations concerning labels and
containers should be respected at all times.
Records should be kept for each delivery. They should include the description
of the goods, quality, quantity, supplier, supplier’s batch number, the date of
receipt, assigned batch number and the expiry date. Where national
regulations prescribe that records must be retained for a certain period, this
must be observed. (Otherwise such records should be retained for a period
equal to the shelf-life of the incoming materials and products, where
applicable, plus 1 year).
Comprehensive records should be maintained showing all receipts and
issues of materials and pharmaceutical products according to a specified
system, e.g. by batch number.
Labelling and containers
All materials and pharmaceutical products should be stored in containers
which do not adversely affect the quality of the materials or products
concerned, and which offer adequate protection from external influences.
In some circumstances, this could include bacterial contamination.
All containers should be clearly labelled with at least the name of the
material, the batch number, the expiry date or retest date, the specified
storage conditions and reference to the pharmacopoeia,where applicable.
Unauthorized abbreviations, names or codes should not be used.
Receipt of incoming materials and pharmaceutical products
On receipt, each incoming delivery should be checked against the relevant
purchase order and each container physically verified, e.g. by the label
description, batch number, type of material or pharmaceutical product and
quantity.
The consignment should be examined for uniformity of the containers and, if
necessary, should be subdivided according to the supplier’s batch number
should the delivery comprise more than one batch.
Each container should be carefully inspected for possible contamination,
tampering and damage, and any suspect containers or, if necessary, the
entire delivery should be quarantined for further investigation.
When required, samples should be taken only by appropriately trained and
qualified personnel and in strict accordance with written sampling
instructions. Containers from which samples have been taken should be
labelled accordingly.
Following sampling, the goods should be subject to quarantine. Batch
segregation should be maintained during quarantine and all subsequent
storage.
Materials and pharmaceutical products should remain in quarantine until an
authorized release or rejection is obtained.
Measures should be taken to ensure that rejected materials and
pharmaceutical products cannot be used. They should be stored separately
from other materials and pharmaceutical products while awaiting
destruction or return to the supplier.
