In logistics, we know that supplying and buying pharmaceutical products can be very frustrating and difficult, mainly due to various regulations and practises in the countries of import as well as in the countries of export.
If you are or you want to become a supplier or buyer of pharmaceuticals, then this article may help you. We gathered all the practises and regulations of warehousing and distribution services for pharmaceuticals, along with the required documentation that you have to be compliant with, in order to be eligible to sell your products across the globe.
The information presented below is according to the Good Distribution Practises (GDP), which are the minimum requirements that intermediaries have to follow from the moment of moving the products from the manufacturer’s premises, to delivering the products to the end user or to another intermediary. GDP is a quality system, which includes practises for storage, purchase, delivery and export of drugs intended for human consumption. GDP applies to all organizations and individuals involved in any warehousing service and distribution practise of all pharmaceutical products.
Storage Facilities and Conditions
1. People without any authority should not be allowed to enter the storage area.
2. There should be sufficient capacity of the storage area to allow the orderly storage of different categories of products such as starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.
3. Warehouse storage must ensure that the quality of pharmaceutical products is maintained and that the stock is appropriately rotated, following the principle of FEFO (First Expired/ First Out).
4. Storage areas must provide sufficient lighting to ensure that all operations are being carried out with safety and efficiency.
5. Pharmaceutical products must be stored in a dedicated area and off the floor and spaced accordingly to ensure cleanliness, repair and inspection of pallets. The storage area must be clean, dry and within temperature limits. Warehouse storage have to be free of waste and vermin and a written sanitation program should be available at the premises. In cases of special storage conditions, temperature and humidity levels should be monitored and recorded.
6. Products must be protected by the weather at all times. There should be reception areas that clean the containers of pharmaceutical products.
7. When quarantine is required, the warehouse storage must be marked accordingly and access should be prohibited to unauthorized personnel.
8. There must be cleaning procedures that ensure complete removal of any contamination. If the sampling of products is conducted in the same storage area, then it should be performed in such a way that it will not risk any contamination.
9. All the pharmaceutical products must be identified even if they have been rejected, expired or returned.
10. Rejected products should be put in quarantine system until further notice.
11. The environmental requirements should be indicated on the product’s primary container. If the container is too small (e.g. an ampule), the information must be disclosed on the most immediate container.
12. Damaged products should be withdrawn and separated from usable stock.
13. Temperature mapping for the facilities’ area must be available for review and recorded for at least the shelf-life of the stored product plus 1 year. It is highly recommended to monitor temperatures especially in areas that are most likely to show fluctuations.
14. In cases of international freight forwarding, the proper languages should be used to ensure that handlers understand the requirements and the specific conditions for warehouse storage.
1. Pharmaceutical products should be transported only if the storage conditions are maintained and the quality of the products is not impaired.
2. Monitoring of transport conditions such as temperature should be available for review, if necessary.
3. The dispatch and transportation of pharmaceutical products can be carried out only after the receipt of a delivery order.
4. Procedures for dispatch and transport should be documented and available for review.
5. The container must be accordingly labelled and must offer sufficient protection from all the external and environmental influences (weather conditions, poor driving skills).
6. The dispatch records should include the date of dispatch, the name and address of the customer, description of the product (name, strength, dosage form, batch number and quantity), and the required conditions for transport and warehouse storage.
7. All these records must be accessible and available for review.
1. Records that describe all the storage procedures, including the handling of expired stock, must be available either in written or electronic form. This documentation should include labelling and storage conditions, precautions and retest dates for every product.
2. The records should be kept for each delivery and should include the description of the product, quality, quantity, supplier, supplier’s batch number, date of receipt, assigned batch number and expiry date. These records should be retained for a certain period according to national regulations. Unauthorized abbreviations, names or codes should not be used.
3. The purchase order and the container’s physical verification must be available and checked on receipt.
4. Every delivery of products should be checked against the purchase order and the container carrying these products must be physically verified. The delivery should be examined for uniformity of the containers and if the delivery includes more than one batch, then the consignment should be subdivided by the supplier’s batch number.
5. The containers must be examined for contamination and damage, and if a leak is observed, then the whole delivery should be put into quarantine.
6. Only authorised and trained personnel can take samples of the products and the containers from which samples have been taken, should be marked accordingly.
7. Following sampling, the products must be put in quarantine until further notice, stored separately.
8. Comparisons of actual and recorded stock must be performed regularly and if any discrepancy occurs, it should be investigated.
9. Damaged containers should not be used unless the quality of the products has not been There should be regular checks and control for obsolete and expired pharmaceutical products.
10. There should be a written agreement among the distributor, the importer or wholesaler and the third-party, that includes all the conditions and procedures.
We know that these may be a lot to take and some of this information is difficult to implement, but we want you to be informed and prepared. And if you still have problems with the warehouse services and the documentation of your pharmaceutical products, then we can help you. Haulystic Innovations is a marketplace dedicated to consult and manage your end to end pipeline operations.
The only thing you have to do is trust us and together we can overcome all the hurdles.
Start your journey with Haulystic Innovations by booking your shipments online.