The esteemed 4Advice is a young and dynamic consultantancy company, founded in September 2015, specialising in international regulations on temperature-controlled pharmaceutical logistics. With EU good distribution practice (GDP) guidelines, WHO GDP chapters and IATA temperature-controlled regulations (TCR) for companies to take into account while operating in this rapidly changing space, its expertise is becoming more relevant and important by the day.

Medicines are meant to save lives, but the quality and effectiveness can only be guaranteed if they are transported under the most optimal circumstances. The company’s mission is to bring added value to the pharmaceutical industry and its global and local temperature-controlled supply chain stakeholders. This means assuring the integrity and quality of human medicines throughout their long and complex journeys via sea, air and land towards their all-important final destinations – the patients.

Lead the way

When the EU GDP guidelines became a mandatory standard in 2013, the entire cold supply chain changed. To become or remain trustworthy partners for the pharma industry, many logistics service providers had to rapidly reorganise and adapt while investing in infrastructure and equipment.

Since then, logistics companies have been on the back foot. The main challenge is to implement and maintain compliance with these many requirements across daily operations. Even respected international logistics service providers still struggle with a lack of expertise, know-how and competence to meet the new risk-based approach standards. With its many different stakeholders and complex cold supply chain, the air-freight industry, for one, faces considerable challenges.

In 2014, Brussels Airport took the initiative, gathering a task force in order to implement standards based upon feedback from pharmaceutical companies in the surrounding area. Using a checklist to sort the EU GDP guidelines, the airport successfully implemented its standards among its ground handlers.

The scheme received such positive feedback from local pharmaceutical shippers that the airport authority contacted the IATA to move the programme further. In 2015, the IATA Centre of Excellence for Independent Validators (CEIV) was born. One of Brussels’ original task force, Bert Elsen, became the IATA’s first independent validator. Elsen is 4Advice’s co-founder. Today, the company he helped start is a strong and reliable partner of IATA. The ultimate goal is to guarantee that pharmaceutical products remain safe and uncontaminated during their long journey from manufacturer to consumer; its three independent validators perform assessments and validation audits all over the world, and each of its employees is in possession of a GDP training certificate.

As a reliable partner of many local and global logistics service providers, 4Advice has many loyal customers in Belgium, France, the Netherlands and Germany, as well as in Canada and the US. All of these partnerships are based upon clients’ written agreements to one vital request – the company needs the support of senior management before it starts a project.

The mandatory GDP/CEIV requirements can only be implemented through the entire temperature-controlled operation if decisionmakers in management are willing to support and authorise the hard decisions that have to be made. 4Advice cares about the need to improve and maintain the quality and integrity of healthcare products even during the operation, and this cannot be done in half steps.

Travel beyond

The company’s goal is to bring solutions, foster continuous improvement and install results-driven best practices that help its customers become experts for themselves. 4Advice makes sure its clients are capable of performing in-house support regarding GDP and CEIV-compliant warehouse projects, operation (re)design, audit programmes, risk and change management processes, lane validations, training and temperature mappings.

"4Advice is becoming a more recognised and appreciated stakeholder in the pharmaceutical industry, where it is asked to bring expertise and added value."

Indeed, one of the major challenges on the road to GDP or CEIV compliance are temperature mappings, which are mandatory technical documented studies confirming if the monitoring system and cool devices used in a temperature-controlled room, unit or truck are fit for healthcare products during extreme seasonal weather conditions. 4Advice has carried out many temperature mappings in winters and summers all over the world. It guarantees its customers that its mapping reports are valid and will stand up to each audit or check done by customers or regulators.

Bringing such added value ensures 4Advice satisfied customers who fully trust its services over the long term. The company is proud that Amerijet, a US freighter, which it supported in becoming CEIV-certified in 2016, recently signed a contract for its online GDP training platform for its blue and white-collar staff in both Spanish and English.

4Advice is becoming a more recognised and appreciated stakeholder in the pharmaceutical industry, where it is asked to bring expertise and added value to international events, workshops and concrete international projects.

Last year, the company successfully launched its own ‘drive.pharma’ event in Brussels, gathering pharma shippers, freight forwarders and ground handlers to discuss the future role of transport companies in the challenging pharmaceutical cold supply chain.
In collaboration with its potential clients, 4Advice can ensure that the quality and integrity of medicines will not be affected during transport.