Do you validate your logistics supply chain currently? If you buy from, or supply to, countries where temperatures are extreme how do you know that your products have been stored and transported within the recomended temperatures required by GDP and the MA for the product?
Do you add data loggers into some or all of your shipments ?
Do you define the time for transit of your goods in order to mitigate some of the risks ?
Do you know if your logistics companies sub contract their work ? What agreements are in place between your logistics company and their contractor to protect your products? Are their staff trained?
How would you make your choice of logistics provider?
Would you audit your logistics company ?
Who will pay for the data loggers and the software required to download the information?
In the new year you will be required to validate your logistics companies and to be able to prove that your shipments are kept within GDP guideline through their journey. Your inspector may ask for this information at your next audit. They may ask for records of both ambient and chill chain products.
Are you prepared for this? Do you have a contingency plan for when it goes wrong? What will you do if the temperature is too low or two high for your product? Have you a SOP in place to cover validation ?
Pharmacy Consulting can help you to prepare for validation, contact [email protected]