GDP requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions. Medicines & Healthcare Products Regulatory Agency
Good Distribution Practice outlines a set of procedures that are to be followed by any EU company with an involvement in the pharmaceutical industry. The guidelines were originally published by the European Council in 1992, contained within an European Directive 92/25/EC. Since the initial publication, the guidelines have been altered continuously, European Directive 92/25/EC has evolved into European Directive 2001/83/EC. Here article 84 and 85b(3) have a specific focus on medicine for human consumption, this is regarded as the core of Good Distribution Practice within the telematics industry.
The most recent amendment formed part of European Directive 2012/26/EU, this extended the guidelines to include pharmacovigilance. This is where drugs are monitored after they have been licensed for use in order to evaluate previously unreported adverse reactions. This could occur due to insufficient management of the medicine during the transportation process, if the vehicle chamber conditions are inadequate the characteristics of the drug may change.
Good Distribution Practice embraces each pharmaceutical-associated firm within the EU, and therefore the amount of information on offer can appear overwhelming. However, as mentioned previously, it is article 84 and 85b(3) that concern the transportation of medical products. The key principles outlined within these include:
Products and shipment containers should be secured to prevent or provide evidence of unauthorised access.
Pharmaceutical products should be stored and transported in accordance with procedures such that appropriate environmental conditions are maintained. For example, a Cold Chain Solution must be used for temperature sensitive products, often referred to as thermolabile.
The required storage conditions for pharmaceutical products should be maintained within acceptable limits during transportation. If a temperature excursion is noted by the entity responsible for shipping it must be reported to both the distributor and recipient.
Where special conditions are required during transportation that are different from or limit the given environmental conditions, these should be provided by the manufacturer on the labels. According to guidelines these requirements must be monitored and recorded.
In short, it is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft. It is also vital to ensure that temperature conditions are maintained within acceptable limits during transport. GDP is effectively a quality warranty system, including requirements for purchase, receiving, storage and export of drugs intended for human consumption.
GDP is monitored within the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA carries out inspections to check if manufacturing and distribution sites comply with the GDP guidelines. Companies will be inspected on application for a manufacturer or wholesaler dealer licence and then periodically with little or no notification, based on risk assessments.
Transcan offer a selection of high-quality products that can ensure GDP compliance during the transportation process, even in the most remote locations. The Transcan® package will play a pivotal role in ensuring that the mandatory environmental conditions are maintained. The vehicle tracking system will be key in sustaining a secure forensic audit trail, this is vital when proving ‘due diligence’ during legal proceedings. Alarm functions within the system will alert fleet managers, as well as the driver when there is a deviation from the essential temperature range. This will allow immediate action to be taken, and therefore will minimise any potential spoilage losses. Full CANbus integration alongside a sophisticated KPI reporting suite will enable pharmaceutical fleets to be managed faultlessly.