What are Good Distribution Practices?19/12/2017 - Martijn Reniers, Managing Partner at Quality by Design
No need to ask Santa about GDP. Ask Sofie!
GDP covers the crucial ‘last mile’ after production. It’s vital that patients receive their medication in ideal conditions. That’s why quality and security need to be guaranteed during the entire supply chain. Sofie Leveque highlights the GDP obligations for pharmaceutical companies and their logistics partners. Logistic partners who provide storage for medication need a GDP licence and are particularly accountable.
Meet QbD expert Sofie Levecque
Sofie studied industrial pharmacy. She discovered and took a deep-dive into GDP at Katoen Natie, a worldwide specialist in logistics, warehousing and engineering solutions. Sofie Leveque regularly provides GDP trainings to the Pharma industry and their logistic partners.
Why are GDP regulations a vital necessity?
Quality assurance of pharmaceuticals must span the entire cycle to be effective. Transport and warehousing is an essential part of this. That’s why GDP is indispensable.
Who needs to comply with GDP regulations?
The regulations apply to pharmaceutical companies and their logistics partners, responsible for shipment and most importantly: storage. Generally, there are two divisions in logistics, the transport and the storage. Firms that provide storage services are required to have a GDP license issued by the FAGG (Belgian authorities). They bear the responsibilities towards GDP.
The Belgian government, and by extension the World Health Organisation, require GDP compliance only from parties that store pharmaceuticals, i.e. keep them at one location for more than 2 weeks. This requirement only applies to the logistics and warehousing companies. They bear the full responsibility for quality and safety and have to open up their facilities for inspection teams.
Transporters, who “store” medicines temporarily (meaning in the awaiting for transportation) do not require a GDP license. They only need to be GDP compliant and have a limited amount of procedures in place.
Sofie, you’ve worked in various pharmaceutical companies. How do they perceive GDP?
Pharma sees GDP as self-evident good practice. Their logistics partners were less enthusiastic at the start of GDP. They often consider the regulations as superfluous and exaggerated. They also worry about the costs involved. Only when you confront them with the possible consequences do they really acknowledge the need. In the end we all have to purchase medication as consumers. So we want to be absolutely sure it is safe.
In a nutshell, how does one comply with GDP-rules?
A risk-based approach is the most important step! Each risk needs to be mapped sufficiently.
The main GDP requirements are: well-trained staff, a perfect documentation system, track & trace, validated software, facility requirements (access control, temperature regulation and protection against humidity, dust and vermin…). Moreover, the quality team of the logistics partner needs to be fully competent.
Another vital element is senior management involvement. Sufficient investments in staff and systems are necessary. Senior leaders also need to initiate and supervise the selection of able subcontractors.
Why did GDP rules become stricter in 2013?
Recently we have witnessed two major evolutions.
First of all the logistics chain has become much more complex. It has expanded from Europe to China. And there’s a continuous flow of semi-finished products. This involves many transporters and subcontractors, which increases the need for seamless control.
Secondly there’s the problem of illegal copies. Pharmaceuticals can easily be forged with placebos or deflected for drug smuggling. That’s why an accurate traceability is really necessary.
How difficult, costly and time-consuming is it to fully commit to GDP?
Setting up a GDP system is no rocket science. But the whole quality system needs to be tuned in. There’s still too much thinking in silos going on. The entire process needs to be a seamless flow. It requires setting up an efficient Quality Management System. Quality itself is a driver of ROI, e.g. by reducing recalls. The principle of Quality by Design is really essential. It is still too often perceived as a mere cost.
How will GDP regulations evolve in the future?
Regulations will become ever stricter due to e-commerce. More and more pharmacists sell online. Today the pharmacy-to-consumer channel is not controlled by GDP. Due to the growing number of online pharmacies this business will probably become GDP-regulated in the near future.