Good Distribution Practices (GDP) in Healthcare: Comprehensive Checklist
To help you prepare for a GDP audit, we’ve compiled a comprehensive checklist for healthcare businesses that want to comply with GDP regulations.
Producing and distributing pharmaceuticals
Pharmaceuticals are something of a special case when it comes to production and distribution. Most governments regulate access to pharmaceutical products, and have more control over its production and distribution than other goods.
Intermediaries in both the public and private sectors working with and distributing drugs have special drug safety and security precautions to take into consideration. For some pharmaceuticals, you’ll need to take cold chain management into account.
What is the Good Distribution Practices (GDP) framework?
Good Distribution Practices (GDP) is a framework that sets the minimum standards distributors need to meet to ensure quality and integrity of pharmaceutical medicines.
Initially created by the WHO and EEC, this quality warranty system regulates the movement and distribution of pharmaceuticals from the moment they leave a producer or central storage point, all the way until they’re received by the end user of the product.
If you want to be authorised to distribute pharmaceuticals wholesale within the EU, your organization will have to comply with EU GDP guidelines and get a GDP certificate, issued by an EU competent authority in the member state in which you operate.
What are the requirements for GDP?
In short, GDP ensures the quality of pharmaceutical products and the integrity of the distribution chain is maintained throughout the distribution process.
According to the European Medicines Agency, compliance with GDP ensures that:
- Medicines are stored in the right conditions at all times, including during transportation
- Contamination by or of other products is avoided
- An adequate turnover of stored medicines takes place
- The right products reach the right addressee within a satisfactory time period
Additionally, the distributor should also set up a proper tracing system. This will help enable finding faulty products and make effective recalls possible.
Without going into too much detail on the specifics of GDP requirements and regulations, it suffices to say that this warranty system for storage and distribution of medicinal products focuses on the following aspects:
- Temperature control
- Packaging quality
- Reliable, functional technology
Implementation of GDP requires a well-thought-out and effective quality management system. But once you’ve set this up and have had it validated and confirmed by a third party in a GDP audit, you’ll officially be a reliable business partner in the healthcare industry.
Why is GDP important in pharma and healthcare?
As a patient, you want to make sure that the medication you take is safe and of the highest possible quality. But medicinal products and pharmaceuticals are often distributed over long distances, through different climate zones, and stored in a large variety of warehouses, before they end up in your hands.
This distribution network is also getting more and more complex. All the more reason for an internationally recognized quality standard for distribution practices.
After all, you wouldn’t want to take a potentially life saving drug not knowing that it’d lost its efficacy due to bad transportation or storage practices, for instance by temperature monitoring failure or low quality packaging.
A comprehensive checklist for GDP in healthcare
During a GDP audit, your quality systems and distribution practices will be checked on a number of factors. To help you prepare for such an audit, we’ve compiled a comprehensive checklist for healthcare businesses that want to comply with GDP regulations.
This checklist is relatively extensive, and will help you on your way to prepare for GDP audits. However, do please refer to the official GDP guidelines set in your country, as this checklist is not in any way intended to replace official guideline regulations.
You can find the full checklist in our downloads section.