Have you considered how you are going to validate your supply chain to prevent the falsification of medicines?

Have considered how you are going to evidence the validation?

From Kali boxes to pallet reefers the market for temperature controlled shipments is vast. Not just the sizing of shipments but the costings of the shipments. The cheapest option of using validated boxes may not be suitable for your business model, but validated shippers can be a costly expense for your products some of which may be low cost items. Remember your client might not want to pay £1000 for a product with a face value of £500.

Firstly, you must consider the size of shipments you will be sending. If you intend to send a pallet worth of product every day a temperature validated box with limited space will be unsuitable. You therefore may want to consider pallet wrapping.

Secondly if you intend on using a temperature controlled box how are you going to ship the box? Which courier are you going to use? The well recognised couriers are likely to charge you more than a local courier. Does this mean you will get better service? Not necessarily remember to the larger couriers you are just a number in a list, and the service you receive can be robotic. If you are a start-up company where you may have what you may deem as stupid questions or require reassurance, the likelihood is the larger couriers do not have the time or patience to spend 15 minutes a day talking to you regarding a 12kg shipment when they have 30 other orders to process. Could a smaller logistics company be the solution? Make sure you choose a company where you are able to build a working relationship with them. Remember the logistics company is just as important to you as the company itself. If you use a non-compliant mode of shipment your company is in jeopardy when an inspector comes to call.

Thirdly if you are sending larger shipments (pallets) shop around for quotes do not settle for the first quotation you receive. Think about where you have to ship the products to, how long the shippers re validated for? If you require a shipment to be sent to the far-east do you send it by air or by sea? If you send it by sea how do you guarantee the shipper will maintain the temperature for a sustained period of time? If you send by air how do you guarantee that the products will not deviate from the temperature when in the aircraft hold at 30,000 feet? Have you taken into consideration the humidity as a factor? Going from a temperate climate to a humid high temperature?

Fourthly, most distributors will turn to Temperature Data Loggers. The next question is which ones do you use? If sending direct to customer will they send you temperature information? If you send a logger that requires a reader could that be facilitated at the destination? If you send a USB temperature logger will the data be easily downloadable? What procedures do you have in place to facilitate this? Remember the reusable data loggers will require recalibration every year.

The transport validation can be a minefield if you need help please contact us on 01252 302 342.