GDP in our DNA – what the European guideline for pharmaceutical distribution stands for
In the Nordic countries, pharmacy customers can be sure that they are purchasing quality products without fear of getting counterfeit, contaminated or wrongly stored pharmaceuticals. This is a result of a unique regulatory environment that aims to guarantee safe and reliable supply of medicines and ultimately patient safety, notes Aino Kylmänen, Oriola’s Quality Director.
Compared with many other consumer goods, handling pharmaceuticals involves unique challenges and complexities, starting from strict regulatory environment and condition control. In the European Union, the key guideline and prerequisite for holding a wholesale distribution authorisation licence is compliance with Good Distribution Practice (GDP). As a part of quality assurance, GDP ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the manufacturer to a pharmacy or a person entitled to supply medicinal products to the public.
In practice, GDP ensures all medicines in the supply chain are authorised in accordance with EU legislation; medicines are always stored in the right conditions; contamination by or of other products is avoided; an adequate turnover of stored medicines takes place; and the right products reach the right addressee within a satisfactory time period.1
These principles are the backbone of our distribution operations. Maintaining product integrity, temperature control, traceability and security is integrated in our processes and ways of working within Oriola and with our partners. Ensuring product safety starts from the moment a delivery enters our warehouse, and for example all products requiring storage in cold temperatures are handled separately. Additionally, we make sure that counterfeit medicines do not enter the legal distribution chain by dealing directly with pharmaceutical companies and by complying with the EU’s Falsified Medicines Directive which entered into force a few years back. This means we verify one product package from each incoming batch as part of normal inspection.
One of the critical elements in handling pharmaceuticals is maintaining appropriate external conditions. If pharmaceuticals are exposed to temperature deviations, product quality might be jeopardised. Most medicines require room temperature between 15 and 25 °C, but some products, such as many vaccines and biomedicines, require cold or even freezer temperature. Due to increased customer needs for special temperatures, we have in recent years invested in modern and sustainable cold chain technology in our distribution centres in both Finland and Sweden.
Reliable and on-time pharmaceutical distribution is essential for healthcare systems and patient care. For most occasions, Oriola delivers pharmaceuticals within 24 hours from ordering. With cold products, it is crucial to make sure that the cold chain is unbroken during storage and transport. Cold products to pharmacy customers are delivered in special cold transport boxes, which are validated to maintain correct temperature for at least 30 hours. To ensure safe and sustainable deliveries to healthcare operators, we in general only use GDP compliant transport partners. This means for example that their fleet is equipped with temperature monitoring and tracking technology for safety reasons, and that their drivers are trained in GDP. Close collaboration with our transport partners is essential, as external transport partners manage Oriola’s entire transport network.
We are continuously reviewing our own processes to enhance the quality of our operations. However, maintaining safe and reliable pharmaceutical distribution is not just about GDP compliant processes but much about people. It is crucial that our employees understand the requirements of our sector and take pride in being part of the healthcare chain to provide people with safe and timely access to medicines. Building this awareness starts from onboarding that includes GDP training, but also from our common values and ambition towards patient safety. This is why we have GDP in our DNA.
Aino Kylmänen works at Oriola as Quality Director. She has years of experience from various responsibility areas at Oriola, most recently from the Quality team for more than 10 years.
1 Source: European Medicines Agency: Good distribution practice