(2003; 148 pages)
5. Storage requirements
Documentation: written instructions and records
5.1 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.
5.2 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.
5.3 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).
5.4 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
5.5 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.
5.6 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
5.7 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.
5.8 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.
5.9 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.
5.10 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.
5.11 Following sampling, the goods should be subject to quarantine. Batch segregation should be maintained during quarantine and all subsequent storage.
5.12 Materials and pharmaceutical products should remain in quarantine until an authorized release or rejection is obtained.
5.13 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.
Stock rotation and control
5.14 Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.
5.15 All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.
5.16 In manufacturing facilities, partly used containers of materials and pharmaceutical products should be securely reclosed and resealed to prevent spoilage and/or contamination during subsequent storage. Materials and pharmaceutical products from containers which have been opened or partly used should be used up before those in unopened containers.
5.17 Damaged containers should not be issued unless the quality of the material has been shown to be unaffected. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
Control of obsolete and outdated materials and pharmaceutical products
5.18 All stocks should be checked regularly for obsolete and outdated materials and pharmaceutical products. All due precautions should be observed to prevent the issue of outdated materials and pharmaceutical products.