Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
GDP Transportation of Medicines
The Transportation of Medicines in Good Distribution Practice
Medicines are essential for the health and well-being of millions of people in the UK. However, medicines are also sensitive products that require careful handling and storage throughout their supply chain, from the manufacturer to the end user.
This is especially true for inland transportation, where medicines may be exposed to various environmental factors and potential risks that could compromise their quality, safety and efficacy. In this blog post, we will explore some of the key aspects of inland transportation of ambient medicines, cold chain medicines, good distribution practice requirements and the training of drivers.
Transportation of Ambient Medicines
Ambient medicines are medicines that can be stored at room temperature, also known as “ambient” temperature. This may be expressed on packaging in different ways e.g., “between 15ºC and 25ºC” or “below 30ºC”.
Ambient medicines can be in any form such as tablets, capsules, creams, ointments and liquids. Sometimes there are no special storage requirements stated, but due diligence would suggest not to allow these products to freeze or be exposed to extreme temperatures, such as direct sunshine for long periods. Even if a storage requirement is not stated, it’s good practice to handle and store it as any other ambient product.
Ambient medicines must be transported in a way that ensures they are not exposed to temperatures outside their recommended range, as this could affect their stability, potency and shelf life.
Some of the measures that can be taken to optimise temperature control during transportation are:
- Use vehicles correctly insulated and prepared for temperature stability within the payload area.
- Do not use vans or trucks with windows in the payload area.
- A bulkhead must separate the driver’s compartment from the payload area.
- Use temperature sensors and data loggers to monitor and record the temperature inside the vehicle.
- Do not use curtain-sided vehicles.
- Follow a defined process to manage and mitigate any temperature excursions.
Transportation of Cold Chain Medicines
Cold chain medicines are medicines that require refrigeration to maintain their quality and effectiveness. These can include insulins, vaccines, injections, eye drops and some antibiotics. Cold chain medicines are often referred to as “fridge lines” or “cold chain products”.
Cold chain medicines must be stored between 2ºC and 8ºC at all times.
Cold chain medicines must be transported in a way that ensures they are kept within the required temperature range, from the point of dispatch to the point of delivery. Any deviation from this range could result in loss (or a dangerous increase of) potency, reduced shelf life or even spoilage of the medicine.
Some of the measures that can be taken to maintain the cold chain during transportation are:
- Using vehicles with refrigerated and insulated payload compartments.
- Using validated cold boxes or insulated containers with ice packs or gel packs. (These cold chain boxes must never be placed in a vehicle that is already refrigerated!)
- Labelling cold chain medicines clearly and separately from ambient medicines.
- Using temperature sensors or data loggers to monitor and record the temperature inside the vehicle or container. (This is strongly recommended when nonrefrigerated vehicles are being used to transport your products.) The temperature logger must be installed in the cold chain box at the point of packing, and not removed until it is delivered and handled by the receiving party.
- Following a defined process to manage and mitigate any temperature excursions. If an excursion occurs, the Responsible Person (RP) must be informed immediately, the goods must be quarantined straight away and the RP must engage the relevant procedures to ascertain the integrity of the product.
Good Distribution Practice
Good distribution practice (GDP) is a quality system that covers the procurement, storage, distribution and transportation of medicinal products for human use. GDP ensures that medicines are obtained from the licensed supply chain and are consistently stored, transported, and handled under suitable conditions, as required by the marketing authorisation (MA) or product specification.
For example, it is not usually acceptable to transport medicines in a vehicle with foodstuffs on board. Medicinal products have been discovered on cold meat trucks with sides of beef nearby, or stacked next to open aromatic fruits. Another was covered with paint after a paint tin split open during transport (unbelievably it was still delivered,) and another consignment was tainted with cigarette smoke in a smaller vehicle with no bulkhead, and a driver who smoked heavily.
Some instances may be permissible subject to a risk assessment (RA). For example, sealed jars of dried foodstuffs would probably not worry a consignment of ambient medicines, as long as they are both kept separate and both are properly packaged. However, the storage requirements of the medicinal products take precedence over that of the foodstuff. If this isn’t possible, then they cannot be transported together.
GDP Training for drivers should also prevent theft. In a known recent instance, a driver attempted to forge a customer signature to indicate a successful delivery, when in fact it was never delivered at all. In-truck CCTV revealed the driver forging a signature and removing the medicine for his own ends. The goods were never recovered.
GDP Training of Drivers
Drivers who transport medicines must have adequate training and competence to perform their duties safely and effectively. Drivers must have a valid driving licence for the type of vehicle they use and comply with all road traffic laws and regulations. Drivers must also have knowledge of:
- The types and characteristics of the medicines they transport.
- The storage and handling requirements for different medicines.
- The procedures for loading and unloading medicines.
- The use and maintenance of temperature-controlled equipment.
- The documentation and records required for transportation.
- The reporting and management of incidents or deviations.
Drivers must also follow good hygiene practices and wear appropriate personal protective equipment (PPE) when handling certain types of medicines, such as Cytotoxic products. Drivers must also respect the confidentiality and security of the medicines they transport.
The transportation vehicle is considered to be an extension of the supplying warehouse and the driver has sole responsibility for the goods on board. This responsibility only ends once the goods are delivered and signed for. This ensures that the quality of the products arriving at their destinations are in the same condition as when they left the supplier or manufacturer.
Conclusion
The transportation of medicines is a vital part of the supply chain that ensures that patients receive safe and effective medicines when they need them. However, transportation also poses various challenges and risks that could affect the quality and integrity of medicines. Therefore, it is essential that all parties involved in transportation follow good distribution practice standards and guidelines, as well as specific measures for ambient and cold chain medicines.
Drivers who transport medicines must also have adequate training and competence to perform their duties safely and effectively. By being a GDP-aware driver, they contribute to the protection of public health and the prevention of falsified medicines entering the legal supply chain.
Training, Support and Advice
If you need guidance or assistance on GDP requirements for transportation or Training for Drivers, you can contact the team at Paradigm Shift Consulting for a free 5 minute consultation on 0330 133 0920. We are an ISO9001 certified consultancy that provides training and quality management services to the pharmaceutical industry. Our team of experts can help you with GDP training, SOP writing, mock MHRA inspections, contract RP services and more.
You can also use our contact form below to provide details of your enquiry.
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