Good Distribution Practices or also known as GDP is the official guideline delivered by the World Health Organization to serve as the standards for transporting and distributing pharmaceutical products in order to maintain their high quality and safety. It is a part of the GxP series of regulations (for example Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice etc.) which are there to ensure that people using the final pharmaceutical products will be safe.
Who needs to comply with the Good Distribution Practice regulations?
The title suggests that the distributors of drugs and medical devices will need to be aware of the standards and in the same time to follow the instructions. This can be the manufacturing company or a third-party distribution organization to every single driver who is responsible for delivering the products.
One of the ways you can make sure you are compliant to the GDP standards is by having a training on the Good Distribution Practice regulations, where you involve all employees that are responsible for the delivery from point A to point B. It is also a great idea to combine it with Good Storage Practice training (GSP) as most of the times you need to store the pharmaceutical products between the delivery.
It is an interesting fact that GDP and GSP guidelines include quality and safety principles about not only products on the market but also drugs and medical devices which are still in clinical development phase. This means that all investigator sites and clinical research organizations need to have a specialized team responsible for the monitoring according to these regulations.
Who regulates the Good Distribution Practices guidelines?
The GDP regulations are international like the rest of the GxP guidelines. Updates usually are published by institutions like the World Health Organization. But of course local, country and region specific, institutions need to implement and interpret the standards into the local or regional laws and regulations. This causes sometimes misunderstanding which guideline to follow, but basically all GDP regulations are the same but amended to the local specific requirements and deadlines.
General Principles of Good Distribution Practices
There are 9 main principles shortly described according to the GDP guidelines:
1. National legislation must make sure to control the distribution process of pharmaceutical products according to the GDP guidelines. (Something we mentioned earlier in this article.)
2. The distributor should be registered and legalized entity, which will be then responsible for the safe delivery of the drugs or medical devices.
3. Only authorized people or companies with appropriate license should be entitled to import or export pharmaceutical products.
4. Distributors can perform a distribution of a pharmaceutical product only in countries where the product is allowed.
5. Distributor are allowed to deliver their services only to companies that are allowed to produce or work with the pharmaceutical product.
6. Duties and responsibilities can be outsourced only to third parties that also hold an appropriate license.
7. Distributors or their agents should supply pharmaceutical products only to persons or entities which are themselves authorized to acquire such products.
8. The person or entity to whom the activity is subcontracted must be appropriately authorized
9. The online sale of pharmaceutical products should be limited to registered and authorized mail-order pharmacies or other authorized entities.
Summary
Good Distribution Practices are strict standards, which apply on an international level. There are some regulations that companies involved in the distribution of the pharmaceutical products need to be aware of starting with the nine main principles of GDP. In order to know more you can register for our free or certified Good Distribution Practice online courses or join one of our webinars. We will be happy to help you get more professional!
