The amended EU directive on good distribution practice (GDP) has been in force since 2013. It transfers many principles familiar from pharmaceutical manufacturing to the distribution of medicinal products. The demands on corresponding pharma logistics processes and transport security are increasing for pharmaceutical manufacturers and logistics providers alike. Safety and GDP-compliant pharmaceutical transports are wholly dependent on consistent quality management - as has clearly been shown since implementation of the GDP amendment.

To ensure long-term successful quality assurance, it is essential to audit logistics processes, to implement quality management structures, and to undertake regular GDP training. As the shipper, pharmaceutical manufacturers generally initiate the first audit of their logistics providers. Increasing numbers of pharmaceutical carriers, however, are also performing audits on their own initiative. Specialists like the European Institute for Pharma Logistics (EIPL), Korntal-Münchingen, Germany, offer external support for auditing, qualification and GDP training.

The current version of the GDP guideline has been in force since November 2013. In principle, the GDP affects the entire logistics chain: first, the pharmaceutical companies and shippers; second, the wholesalers and distributors; and third, the pharma logistics firms, who are responsible for safe transport of the sensitive goods to the end customer.

The shippers have to ensure that they (if they have their own fleet of vehicles), but especially their external logistics providers, can prove use of GDP-compliant processes. Logistics firms must prove they have the right equipment, trained personnel and compliant pharma logistics processes. Let us focus on pharma transports.

Vehicle Qualification

Once processes are clearly defined and communicated within the company, the next step is to audit the vehicle fleet to ascertain whether the vehicles (still) comply with the latest pharma transport criteria. External consultants also assist carriers in this area.

The first step is to create a specification defining requirements, as part of design qualification (DQ). Equipment on pharma trailers includes, for example, three-point-calibrated temperature sensors, door contact locks and refrigeration units for multichamber systems. If the refrigerated vehicle is already built, it is checked to ascertain whether the necessary elements have been installed correctly (installation qualification, IQ) and are also working properly (operational qualification, OQ). Once the vehicle is operational, the performance qualification (PQ) is undertaken, which checks the system in operation.

Best-Practice Example: IJS Global

With around 600 employees, IJS Global is an international logistics provider with customers in over 50 countries. Its specialties include pharma logistics in multimodal, temperature-controlled transports - with a focus on airfreight, a particularly sensitive sector with numerous security regulations. Because of this focus, the GDP amendment resulted in a few optimization tasks along the supply chain.

The pharma logistics experts from EIPL were brought in to analyze processes and determine specific actions needed. The aim is full GDP certification for all pharma logistics activities.

"Naturally, we were able to build on some existing internal standards," said Christoph Schneider, head of IJS Global's German main branch in Kelsterbach near Frankfurt am Main. "Nevertheless, it quickly became clear following the first inventory that documentation and internal communication to staff needed to be upgraded."

Next, IJS and EIPL defined 12 theme areas for quality management, which are either ISO- (International Organization for Standardization) or GDP-relevant. The partners created new procedures and clarified responsibilities where existing QM processes were partly or completely insufficient for GDP requirements.

"For example, contracts with customers and suppliers need to be clear, to ensure precise definition of the areas of responsibility," Schneider said. "Specifically, this means who evaluates the data logger from the temperature-controlled transport and how the person responsible proves the required temperature range was maintained throughout the shipping process."

Here the IJS Global branch manager noted that the temperature controls performed by logistics firms for HGV transports are now a realistic option, which is completely in contrast to air transports with dispatching and receiving stations where the local infrastructure is incomplete or missing. This is because the goods are on the airlines' or the airport operator's territory as soon as the shipment is handed over to the airline - which can lead to difficult control conditions as a result.

Schneider: "We are also working with our partners from the individual airlines, though, on solutions to facilitate appropriate documentation and an optimum Cool Chain - using fact sheets for airlines or SOPs, for example, which are coordinated globally with all supply-chain participants."

Once the documentation processes were optimized, IJS Global needed to train its staff to use the new additional workflows - also with crucial external support. There have been two in-house training sessions to date, in which the external pharma logistics experts explained not only the GDP rules to the team, but also specific realization in their own firm, including the newly created responsibilities, documentation requirements, conduct in the event of deviations, worst-case scenarios, etc. This regular training is a central component of the firm's QM strategy.

Quality Of Pharma Transports

The GDP amendment enables pharmaceutical companies to consolidate and strengthen the requirements they place on logistics providers in terms of transport quality and safety. This requires clear processes; consistent quality management, including cleaner documentation; GDP-compliant, suitable vehicles; and correspondingly trained personnel.

GDP Amendment 2013

The key legislation for pharma transports in Europe is the EU GDP directive, more precisely the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use. The 2013 amended version of the GDP guidelines is derived from the global GDP guidelines of the World Health Organization, which has also published Good Trade and Distribution Practices for Pharmaceutical Starting Materials (GTDP). The final version of the GDP guidelines has been restructured compared with the draft version. The directive is divided into the following 10 chapters: Quality Management, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced Activities, Contract Manufacture and Analysis, Complaints and Product Recall, and Self-Inspection.

EU directives like good manufacturing practice (GMP) and good distribution practice (GDP) set the legal standards - transposed into national law in Germany by legislation including the Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV). The GDP amendment applies the known principles of good manufacturing practices from pharmaceutical manufacturing to the transport of medicinal products. Specifically this means that continuous process controls - particularly with regard to temperature - are subject to much tighter regulation. This means that monitoring and documentation of transports also take on a much greater significance.