Handle with great care

Just like manufacturing, the distribution of pharmaceutical products requires specialist skills. Ken Brown, from UCI Logistics, discusses the requirements

Just as pharmaceutical manufacturers are subject to some of the most stringent regulations in the world, so their suppliers must demonstrate their ability to meet requirements and quality standards in the transportation of pharmaceutical products. The EU's 'Guidelines on good distribution practice of medicinal products for human use', requiring those involved in transportation to ensure that:

their identification is not lost

they do not contaminate, and are not contaminated by, other materials

adequate precautions are taken against spillage, breakage or theft

they are secure and not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence, or to attack by micro-organisms or pests

pharmaceutical products requiring controlled temperature storage should also be transported by appropriately specialised means

product returns should be subject to similar controls and quality standards during transportation to those applied during deliveries

This level of quality must be maintained throughout the distribution network so that authorised medicinal products are distributed without any alteration of their properties.

When that network covers an entire continent, the management of subcontracted distribution is, in itself, a highly complex task. While the obvious solution for manufacturers is to appoint a single contractor, in reality, pharmaceutical manufacturers export to so many areas that it is simply not possible to find one company with the necessary resources, knowledge and expertise.

By necessity, therefore, most manufacturers rely on a number of suppliers to distribute their products.

To ensure that their statutory requirements are met, the contractors they select must meet core requirements in respect of their operational, security, quality and administrative procedures.

For example, manufacturers must be able to provide conclusive proof that the correct temperature ranges have been maintained during transit.

Contractors must therefore operate temperature-controlled vehicles and be able to guarantee temperature accuracy. They must also continuously monitor in-transit temperature using specialist equipment, with back up in case of failure. Specialist contractors may also employ new technology which links onboard transit temperatures to the trailer satellite tracking system which permits the temperature to be monitored and controlled remotely.

Ongoing management of contractors is also essential to ensure that agreed service and quality levels are maintained. Manufacturers must therefore implement formal and comprehensive audit, performance measurement and disciplinary systems to ensure that multiple suppliers meet and continue to comply with strict operational procedures - a highly complex and time consuming exercise.

An alternative solution is to outsource this management function to a specialist logistics service provider who, in addition to assuming responsibility for the appointment and management of contractors, can optimise operational efficiency across the whole of the supply chain.