The time period for adapting to the regulations on good distribution practices in the distribution of medicines for human use in Spain came to an end on the 20th of April 2014. The coming into force of Spanish Law 782/2013, of the 11th of October, on medicine distribution activity, marks a beginning and an end to the way in which TRANSPORT activity for the pharmaceutical sector is understood.
Integra2 is an extensive transport network whose objective has been to provide efficient and effective solutions to the laboratory since the very beginning. Since then, providing the highest quality service and greatest added value in transport has been one of the main concerns when every strategic decision has been made by our organisation. This is how we came to have our extensive, temperature-controlled distribution network, launching exclusive services for thermolabile products, adapting the fleet and installations, providing personnel with training and directing an organisation of over 2,000 professionals towards a business culture that goes far beyond just transporting goods. An organisation prepared for DRIVING HEALTHCARE.
During Integra2’s 25-year existence, we have taken on board the different recommendations, guidelines, and advice on good pharmaceutical distribution practices, which have come to us via the World Health Organisation, the European Parliament and Council, the European Health Commission and Spain’s own rules and regulations. All of them have a fundamental guiding principle, the management of the medicine supply chain in order to protect the integrity of the medicine, avoid falsifications, watch over the stability of the system, etc. This regulation has been supplemented by the new Good Distribution Practices for medicines for human use.
The daily work, hand in hand with logistics professionals from the pharmaceutical sector, has been the biggest and best help in our development. Along with them, we have learnt what is important and what is urgent. We have set up a delivery system for the Spanish pharmaceutical channel (hospitals, health centres, pharmacies), adjusted to meet real requirements, directing our organisation towards specialisation in the sector and investing in quality all of the time.
Just over a year ago, in the logistics and transport decision making process, the laboratory’s technical management team and quality guarantee came directly into play, corresponding precisely with the aforementioned Good distribution Practices for Medicines for Human Use (GDP). This has allowed us to move forward much more quickly when it comes to GDP, by especially focussing our efforts on Quality Management, Personnel, Externalised Activities and our own Transport process.
For Integra2, and thanks to our historical emphasis on quality and the pharmaceutical sector, the adaptation process has been a natural and non-traumatic one. We have reviewed the control points for the different stages of the transport process, improving our processes in order to improve in key areas such as:
• Shipment traceability
• maintenance of temperature conditions (2ºC-8ºC, < 25ºC)
• making cross contamination impossible
• prevention of theft, robbery or falsifications
To this day, the effort made has produced significant results, which the pharmaceutical sector is benefiting from.
All of our vehicles are also equipped with systems for maintaining the temperature and undergo a validation and qualification process. The equally validated and qualified hubs have two different temperature zones (2ºC – 8ºC and <25ºC). We have brought pharmaceutical personnel into our organisation, multiplied the number of professionals trained on GDPs by six, and more than doubled the number of temperature probes and recordings with which we are able to monitor, control and demonstrate the maintenance of the temperature during shipment.
In April 2014, we carried out a survey in the Spanish pharmaceutical sector in order to find out about the impact of the new GDP regulations on the distribution of medicines for human use. The survey was carried out using more than 100 people responsible for logistics and transport areas, technical management, management departments and general management of pharmaceutical laboratories, distributors, wholesalers and logistics operators. The conclusion of the survey demonstrated that the sector is proactive in adapting to the regulation changes. At the moment, 25% of those surveyed have carried out some kind of audit on all of their transport providers and 20% have audited at least one of them. In addition, 31% of those surveyed have already signed technical agreements with all of their transport providers and 29% have done so with some of them.
No less than 85% of those surveyed considered that Integra2 is the best prepared transport company with regard to complying with GDP requirements in Spain, strongly backing up the strategy adopted by the company and representing a great responsibility when it comes to continuing to meet the demands and keep improving in all of the areas that the demanding pharmaceutical sector requires regarding the specialised transport of medicines for human use.