Tackling the pitfalls of pharma distribution

Taking a look at quality assurance factors to be taken into consideration when choosing a logistics and transport provider for the distribution of pharmaceutical products

The cold chain transport of pharmaceutical products is currently a particularly ‘hot’ topic. Pharmaceutical manufacturers and distributors are required to adhere to defined guidelines on the production, packaging and supply of medicinal products for human use1. It is the responsibility of the product licence holder to ensure that the product is stored and transported under the appropriate conditions throughout its life. These conditions shall ensure that quality and efficacy will not be adversely affected therefore assuring the primary goal, and responsibility for patient safety. Optimum conditions for storing and transporting a product are defined and registered during product development.

Many pharmaceutical products require storage within defined temperature or humidity ranges, as shown during stability and accelerated stability studies. The product may have been shown to deteriorate or degrade outside of these conditions and must, therefore be carefully managed and controlled during storage and transport. There must be full documented evidence to show that all the appropriate conditions have been satisfied throughout the custody chain and the responsibility of each party must be clearly stated as part of a formal contract or agreement.

When pharmaceutical material is transported, by whatever means, the containers used to hold product must be temperature controlled. In the case of sea or air transport, the containers should be validated and/or qualified to show that appropriate conditions are maintained throughout the entire journey. Where temperature controlled vehicles are used for overland transport, the vehicles must be shown to be able to maintain stable, and uniform, temperature and storage conditions. When choosing a logistics provider, there are many issues that should be taken into consideration. The logistics provider’s ability to provide assurance that they have adequate control over the temperature of the vehicle and their awareness of the requirements of the pharmaceutical industry must be considered. The ability to be flexible to the specific requirements of individual customers, for example, their reaction to out of specification readings or power failure during the journey should be evaluated.

Having had experience working with pharmaceutical supply chains and close working relationships with logistics and transport partners, I have audited both. To audit a logistics and/or transport provider on behalf of a pharmaceutical company there are particular areas to take into consideration regarding the general compliance of the logistics provider/transport company, to pharmaceutical quality requirements.

Quality system
A transport company that intends to provide a service to the pharmaceutical industry, must be both aware of and working to, the relevant sections of Guidelines on Good Distribution Practices (GDP)2. It is important that all staff (including drivers, office staff and senior management) are aware of these and other good practices adopted by the industry so that they can appreciate the reasons for the stringent regulations. There should be documented evidence of this awareness. The implementation of a quality documentation system, whether the company intends to aim for recognised certification (e.g. ISO9001:2000) or not, will highlight the company’s strategy and policies, for marketing purposes, and its commitment to defined standards, these may often be defined in a Quality Manual. Under this system, as an example, the following procedures might be expected, but not limited to: the loading of vehicles and containers, definition of the types of goods that may be carried, journey planning procedures, the cleaning and decontamination of vehicles, staff recruitment and driver security, and contingency plans.

Vehicle control
Although the vehicles themselves are central to the transport operations, they are essentially an integral component of the overall transport system. The vehicles should be temperature mapped, and qualified/validated, and records generated and retained to show that these activities were performed and successful. Temperature mapping is used to identify hot/cold spots within the vehicle and any temperature gradients across the load.

• Qualification of the vehicle may include test on the alarm systems, defining the location and calibration of monitoring devices, and tests to any cooling system back-up (e.g. generator). Validation of the vehicle should take into account variations in the environment external to the vehicle when travelling through different countries and during different seasons. Procedures should be in place to ensure that the vehicles are dedicated for pharmaceutical use and are maintained to an appropriate level of cleanliness.

• Any shipping containers used should be qualified/validated.

• An adequate and effective system for tracking the vehicles should be in place and proven. Today satellite tracking systems are commonplace and allow the customer to follow the progress of the vehicle, and hence the product, to its destination. Such systems may allow remote monitoring of the temperature within the vehicle, and may include details about the driver’s qualifications.

• Each vehicle may carry a set of procedures for the driver’s use, e.g. emergency procedures in the language of each country through which the vehicle will travel.

• The vehicle itself must be maintained according to in-house procedures, e.g. the maintenance of the cooling system, routine calibration of the temperature monitoring systems, temperature probes, and emergency generator.

• The temperature monitoring devices must provide continuous records and printouts of the temperature within the vehicle during the journey which should be available to the receiving warehouse/customer, and provide a permanent record of the journey.

Personnel and security
All staff should be trained in the requirements of GDP, additionally all drivers would be expected to be trained in the procedures for loading and unloading the vehicle, management of the vehicle during transport, and emergency procedures. Drivers should be trained and/or certified in the handling of hazardous materials. Consideration should be given to the Security Standards employed when handling and transporting any pharmaceutical products. If the product to be transported, however, is a controlled drug, then the logistics provider must be fully aware of Home Office Regulations and Guidelines that apply to the storage and movement of controlled drugs, for example: the requirements for double-manned vehicles, and specific driver training. For countries outside the UK, there must be compliance with the relevant legislation applicable to the country through which the product will be transported.

Audit and Review
Once selected, the transport company should be reviewed and audited regularly, to ensure that appropriate standards are maintained and the quality system is effective. Regular review will help to maintain an effective working relationship, this is important when specific requirements may be made by the pharmaceutical company. A technical agreement should be set up between the transport company and the product licence holder. This should clearly define the responsibilities of all parties and the procedures to
be followed when problems arise.

By Sarah F Kings, Quality Assurance Advisor
enquiry number 05108

References
1. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002
(The Orange Guide), MHRA
2. Guidelines on Good Distribution Practices of Medicinal Products for Human
Use (94/C 63/03)

Recommended Reading
3. Recommendation on the Control and Monitoring of Storage and Transportation
Temperature of Medicinal Products, J Taylor, MHRA