
Receipt of incoming materials:
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.
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.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.
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.
Storage requirements:
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.
The pharmaceuticals products should be store as per following labeling instructions are recommended:
On the label Means
“Do not store over 30°C” from +2°C to +30°C
“Do not store over 25°C” from +2°C to +25°C
“Do not store over 15°C” from +2°C to +15°C
“Do not store over 8°C” from +2°C to +8°C
“Do not store below 8°C” from +8°C to +25°C
Protect from moisture” no more than 60% relative humidity in normal storage conditions; to be provided to the patient in a moisture resistant container.
“Protect from light” to be provided to the patient in a light-resistant container.
To add on this, store in DRY PLACE on the label is RH NMT 40%
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