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Cold chain management and transportation of medicines

Published on 11/08/15 at 09:38am
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Riekert Bruinink, a member of the guideline drafting committee and the Dutch health inspectorate, has a very simple explanation of the aims of the updated EU Good Distribution Practices guidelines.

As he told delegates at a European logistics conference when the updated guidelines were published: “When we are talking about GDP, we are talking about the patient, and about the quality of the medicines that reach the patient. It is important that they can trust their medications. You can find counterfeit products everywhere in the world, and they are growing.”

At the time, the long-anticipated EU Good Distribution Practices (GDP) guideline had finally been published in the Official Journal of the European Union by the EU Commission, in March 2013. It replaced the earlier 1994 guideline, and requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and also handled under suitable conditions, as is required by the market authorisation or the product’s specification.

The update brought with it a change in the perception of who the responsibility for transporting products lies with, such that the GDP guidelines are no longer perceived as solely the drug manufacturer’s responsibility. It applies not only to the wholesalers and manufacturers of drugs, but also incorporates the specific requirements for brokers who deal with pharmaceutical products. It places the responsibility for the product during storage and distribution with the manufacturers up to the point of sale, and then wholesale dealers take ownership of the products after its sale.

New WHO model guidelines

Since then, other organisations have added their own requirements for cold chain management and distribution. During the World Health Organisation’s last (WHO) executive board meeting in March 2015, an expert committee presented a report from the 49th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. This report put forward model guidelines, which were adopted and recommended for use by WHO, on the requirements for the safe storage and distribution of timeand temperature-sensitive products (TTSPPs).

Although they are best practice guidelines, the intention is that the they should be directly applicable globally, including in less economically developed countries, WHO says. And “its experience with vaccine supply chain assessments in many less economically developed countries demonstrates that the mandatory standards set out in the guidelines can be achieved, and that some countries are also capable of meeting many of the optional requirements.”

In the case of vaccines, the $ 1.4 million investment by the Bill & Melinda Gates Foundation – in an innovative refrigeration technology to bring a life-saving vaccine cooler to market – highlights the need to maintain vaccines at appropriate temperatures to ensure patient safety, and to help save lives. Temperature deviations throughout the journey require the establishment of a complete logistical process to maintain the shipment integrity. Therefore dialogue, joint strategy, and standardisation within the supply chain is required.

Changing drug transportation needs

There is now an increasing number of regulations around the world to implement and comply with. Yet the pharma industry is heavily regulated with no global standards and certification for handling of pharmaceutical products. Taking a risk-based approach to compliance planning, execution, and monitoring makes good business sense in a heightened regulatory environment.

To help companies improve their cold chain and transportation standards, the International Air Transport Association (IATA) has established a centre of excellence for independent validators, to maintain the integrity of medicines throughout the distribution supply chain and improve the handling of and compliance with regulations and standards.

Ronald Schaefer, who is project lead at the Center of Excellence for Pharma Logistics at IATA, says: “IATA is addressing the pharma industry’s concerns by developing the new Center of Excellence of Independent Validators in Pharmaceutical Logistics (CEIV), to give pharma firms more confidence that companies such as airlines and ground handlers are meeting and are in compliance with the international regulations such as the EU GDP, national GDPs where applicable and WHO guidelines.”

Pharma transportation certification

For airlines and aviation companies, all personnel who are involved in handling pharmaceutical products should be trained on the IATA Introduction to Time and Temperature Pharmaceutical Products course, or an equivalent, within 12 months of certification. Recertification will take place every two years – and will include an assessment and one refresher training session, plus a validation exercise if necessary.

Josiane Van der Elst, who is director-general of inspection for medicines and health products for the Belgian government, says: “Although this type of IATA certification is n’t an authority-issued regulatory document, initiatives of structured control on transport are important and welcome. The IATA certification gives more confidence that pharmaceutical air freight shipments are handled in accordance with EU GDP ”.

Different firms cope in different ways with the implementation of the GDP, because their activity in the supply chain varies and would thus implement the part of the requirements that is applicable for its activity. But as Schaefer says, “everyone in the supply chain always has room to improve”.

Improving this will take much more communication and cooperation, from the start to the end of the supply chain, and interaction with industry regulators. The industry needs to take a supply chain approach - one where each segment of the healthcare supply chain must understand their roles and responsibilities. It starts with the healthcare industry, understanding the complexity of the full supply chain and getting more involved with its service providers and between the supply chain stakeholders.

Schaefer concludes: “In order to deliver, supply chain partners will need to collaborate on standards to ensure seamless integration of cargo movements throughout the process. “The aviation industry, the airlines, ground handlers and even airports are investing a lot in enhanced processes, systems, infrastructure and training, which is not always known to the healthcare industry and thus the IATA CEIV program provides better visibility of who can do what and where.”

IATA will be presenting their CEIV pharma programme at the Fly Pharma conference in London in September 2015. To register visit: www.flypharmaconference.com

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