Pharmaceuticals in Supply Chain
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.
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.
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.
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.
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.
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.
Dispatch
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.
Documentation
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.
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.
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.
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