Definition of Good Storage Practice
Conditions under which medicinal products are maintained can affect their final quality as well as their merchantability. For this reason, Good Storage Practice requires all pharmaceutical products to be stored in the most adequate ways and in the most proper conditions in order to ensure that their quality will not be compromised and no unanticipated consequences will occur after these products reach consumption. Storage plays an integral role in the total drug control system. Of course, proper environmental control must be implemented every time pharmacy stock and supplies are stored in the premises. The proper environmental control and conditions include proper light, temperature, and humidity, conditions of sanitation, ventilation, and segregation. All of the drugs which are in the premises are supposed to be kept under strict conditions which preserve the products from contamination and/or deterioration. Moreover, it is of a great importance for the storage of medicines to follow the requirements and directions of the manufacturer and to be compliant with the terms of product authorizations. The storage conditions of pharmaceutical products must be appropriate to the stability and the nature of the product itself.
Receipt of incoming materials and pharmaceutical products
On receipt, each incoming delivery is required to be checked against the relevant purchase order and each container should be physically verified, e.g. by the label description, batch number, type of material or pharmaceutical product and quantity.
Furthermore, it is important that the consignment is inspected for consistency of the containers and, if necessary, it should be subdivided in accordance with the supplier’s batch number in case the delivery has more than one batch.
Each container should be carefully examined for possible contamination, tampering and damage. Any suspect containers or the whole delivery, if necessary, should be quarantined for additional examination. On required, samples can be taken only by well-trained and experienced personnel. The procedure should be done in thorough accordance with written sampling instructions. Containers from which samples have been taken should be labelled properly and accordingly.
After sampling, the goods should be subject to quarantine. Batch segregation is supposed to be upheld during quarantine and all subsequent storage. All materials and pharmaceutical products should remain in quarantine until an authorized release or rejection is obtained.
The appointed professionals should take adequate measures in order to guarantee that rejected materials and pharmaceutical products cannot be used. Such products should be stored separately from other materials and pharmaceuticals while awaiting destruction or return to the supplier.
Distribution and storage is a very important activity in the supply chain management of the manufacturing of pharmaceutical products. The objective of the GSDP guidelines is to ensure the quality of pharma products during the whole distribution process. Furthermore, it sets out appropriate steps to assist in fulfilling the responsibilities and to avoid the introduction of counterfeit products into the marketplace. In order to know more you can register for our free Good Storage Practice course . We will be happy to help you get more professional!