Practice makes perfect

Good practice compliance is becoming more important during the transportation of investigational products, but meeting all the necessary regulations can prove a complex task. Michael Fleischer, regional quality manager NCEE at World Courier, explains why pharmaceutical companies need a logistics partner that is one step ahead of regulatory developments.

What is World Courier�s involvement with the clinical trials sector?
Michael Fleischer: World Courier was founded in 1969 in the US. We started off hand-carrying document shipments all over the world, and then developed emergency parts logistics. Today, 85% of our business volume is shipments for the biopharmaceutical industry. We serve the industry from two sides. On one side, we provide good-practice-compliant distribution of investigational products to depots and sites and, on the other side, we transport patient samples from sites to a central laboratory. We have been involved in more than 10,000 clinical studies worldwide.

Could you underline the importance of good practice compliance, and explain the role it plays in servicing your biopharmaceutical customers?
The pharmaceutical industry is one of the most regulated in the world. When transporting investigational products, it is important to comply with good distribution and storage practices, as well as parts of good manufacturing and clinical practices. These principles need to be adhered to if the clinical trial is to be approved and its results accepted.

What are the principal challenges faced when it comes to ensuring compliance on an international basis, and how does World Courier meet these demands?
We think there are two main challenges. Firstly, there is no universally accepted good practice standard � the rules are different in different parts of the world. Secondly, it can be hard to find a reliable quality standard from country to country. In both cases, it is crucial to find a partner with a global network and transportation specialists who are always one step ahead of regulatory developments.

The emergence of new markets in clinical trial sectors has made this even more challenging. Nowadays, investigational products have to be transported over much longer distances, involving language barriers, different time and climate zones and complex import procedures. So maintaining the cold chain can be a tough task, particularly in the case of unforeseen circumstances.

World Courier operates a global network of approximately 150 offices in 50 countries. All our offices are ISO 9001 and 14001 certified, and operate according to a set of global standard operating procedures, which have been specifically developed with good practice compliance in mind. Compliance is enforced by a fully independent global and regional quality department.

Why are risk management strategies important within logistics?
Firstly, it is necessary to show that all GMP standards are met during manufacturing, and that the quality of the product is maintained during transportation. For this, it is necessary to make the right choices and use appropriate protective transport containers and calibrated devices to monitor the temperature.

The second area of risk management is related to business continuity. Transportation doesn�t happen in a laboratory and there is no guarantee that everything will go as planned. Our principle of non-consolidation individual shipment handling ensures we can react to unforeseen disruptions.

What sets World Courier apart from other companies offering similar services?
The size of our network and our uncompromising commitment to the highest quality services sets us apart. There is no competitor in the market with a similar number of offices spanning the globe.

We always offer tailor-made transport solutions that cater specifically to the requirements of the individual shipment. Dedicated in-house software solutions help us manage even complex requirements, and all relevant data for individual protocols are administered in a central database.

World Courier's 'OK to send' procedure ensures that all import and export processes are verified before the shipment is on its way but, in case there is a delay, we can access the shipment for dry-ice replenishment or exchange of cooling media.

What are the important market trends in 2013?
The regulatory environment is becoming increasingly complex, focusing more on transportation processes. Uncontrolled ambient shipments are almost entirely a thing of the past, and instead we have seen an increasing demand for controlled ambient shipments in the 15�25�C range.

The requirement to work with qualified partners is also increasingly enforced. Only service partners that can offer a stringent quality management system and highly skilled staff, as well as the right kind of qualified and calibrated equipment, can be prepared to meet these industry demands.