Implementing GDP Without Getting Lost in Side Issues
A burning sun, a mild, rainy day or intense snow storms
Just a few examples of the climate conditions that exist worldwide. Where medication is made and stored under controlled conditions, transport can sometimes be a real challenge.
Transport is usually outsourced to third parties, and you can probably imagine that circumstances in African countries, for example, are different than in the Netherlands. It is because of these factors that the regulations have become more specific since 2013. Good Distribution Practices (GDP) seems, in many respects, very similar to the GMP (Good Manufacturing Practices) guidelines, supplemented with some specific topics.
Our experience at PCS is that many companies have questions about how the implementation of GDP can best be tackled. Where do you start? How do you validate transport routes, qualify your transporters and set up proper contracts? In other words, how do you ensure that you meet expectations without losing sight of the logistical process?
These 5 Steps Help You Keep An Overview And Make The Right Choices:
Step One: Provide a project leader who will manage this process. The project manager ensures focus and follow-up. You may want to do this yourself, delegate it to a colleague or outsource it to a hired consultant from, for example, PCS.
Step Two: Map the logistical process. The logistical process is reasonably straightforward. The material comes in, it is stored, and goes out again. In actual practice, this can be divided into many steps. The real-life, expanded logistical process should be your primary (core) process. All systems around it are for supporting purposes only.
Step Three: Perform a baseline-assessment and figure out your current compliance level. You look at what is already there (in compliance) and where the gaps are (out-of-compliance). PCS works with a spider web model so that the current status and attention points are continuously measurable.
Step Four: Put the action points in an overview, involve the process owners, determine the priority and the deadline.
Step Five: Follow up- and execute the actions. This may sound like a platitude, but this is where many projects go wrong. No change without action. Improvement is achieved through implementing the planned action-points step by step.
How to Proceed?
As you may well imagine, well-founded knowledge of the GDP rules is indispensable to implement this approach. Know what you are talking about. And if you do not have the knowledge just yet, make sure you inform yourself of the current guidelines. You can find the most recent guideline for distribution of medicines for human use here
If the guideline does not provide sufficient guidance, or if you need training in the most important GDP aspects you may navigate to our courses page for GDP training.