Transport of meds – everything you should know about it

Transport of meds is one of the most demanding types of transport, which is caused by the characteristics of pharmaceuticals themselves. Each interference or change in transport conditions may cause irreversible changes in the transported goods, and consequently pose considerable risks to patients’ health or lives.

So, what environmental conditions must be maintained?

• Appropriate transport temperature – the foundation of each transport order is the information what temperature conditions must be maintained in the cold room. Most often, meds are transported in temperatures +15C/25C and +2C/+8C
• Appropriate air humidity

Due to the cargo specificity, companies involved in transporting pharmaceuticals have to satisfy certain requirements and guidelines to guarantee appropriate transport conditions and make sure that the cargo will reach its destination complete and unaltered. The legal regulations that need to be followed in this respect are the Pharmaceutical Law and the Good Distribution Practice Guidelines.

1. Requirements in transport of meds

So as to provide top-quality transport services, the carrier should satisfy a number of requirements which need to be fulfilled by:

• the staff involved in the process of transporting pharmaceutical products
• the quality management system
• the equipment of vehicles

Staff

Each employee involved in the processes of planning and execution of pharmaceutical transport should have relevant qualifications. For example, the driver needs to take part in an introductory training, during which they will learn how to transport medicinal products in a correct manner. Driver’s Manuals are a good solution – after the training the driver will be able to consult them at any time. They contain all requirements and guidelines that need to be adhered to by the driver during the process of completing each order. Additionally, drivers should take part in a refresher training at least once a year.

Each newly hired driver should submit a clean criminal record certificate in order to secure top security standards of the transported cargo.

Office workers (forwarders, administrative workers) should undergo introductory and refresher trainings. A good solution allowing employees to improve their knowledge on a permanent basis is delegating them to external trainings devoted to the Good Distribution Practice in transport.

All workers should complete necessary documents after every training is completed, in order to verify whether the training was effective and to document their participation. For example, it could be quizzes and signatures on attendance lists.

In each company involved in the transport of meds there should be a Responsible Person appointed, in order to secure top quality standards and guarantee adherence to the Good Distribution Practice guidelines. Such person makes sure the required procedures are adhered to on an everyday basis.

Quality management system

Each carrier participating in the process of transporting medicinal products must hold the Good Distribution Practice certificate and have the quality management system implemented. This entails the need to follow a number of guidelines relating to internal processes and procedures. Besides maintaining the required temperature, the transport of meds needs to satisfy a long list of obligations relating to internal structures.

Legal requirements in the international transport of meds

In order to be authorised to transport meds in Poland and the European Union, it is necessary to have the GDP certificate. The certificate guarantees maintaining appropriate quality and integrity of pharmaceuticals over the entire supply chain and prevents introducing falsified products in the lawful supply chain. The Good Distribution Practice certificate is issued for 3 years, during which supervision audits are carried out. It is a good practice, aimed to make sure that the requirements defined in the standards are constantly fulfilled during the validity period of the certificate.

What does a transport company have to guarantee in order to provide transport services compliant with the Good Distribution Practice guidelines?

• quality management system in terms of distribution of medicinal products,
• maintaining appropriate transport conditions,
• strict requirements in terms of staff selection – constant improvement of qualifications of workers participating in the transport of medicinal products through introductory and refresher trainings,
• procedures on transport of medicinal products, drivers’ hygiene, cleaning and disinfecting the cold room, documentation supervision,
• mapping of the cargo space, deviation management,
• ongoing control of transport conditions

More detailed information on the GDP requirements for transport

Vehicle equipment

Each refrigerated truck participating in the transport of meds must satisfy a number of requirements in order to be approved to accept this type of cargo.

What documents must a refrigerated truck have?

• ATP certificate,
• measuring sensors calibration certificate,
• cargo space mapping certificate,
• Cleaning and disinfection logbook with current entries confirming recent cleaning procedures,
• technical inspection of the cold room and the cooling unit with current inspection results,

Each transporting company involved in the transport of pharmaceutical products must be aware of the risk posed by thefts of meds. A number of state-of-the-art protections are applied in order to secure vehicles against actions of any third parties.

What protections are they?

• alerts on unauthorised access to the cargo space,
• mechanical SBS locks protecting the door of the cold room,
• electronic locks in semi-trailers, which can be opened only from the forwarder’s computer,
• panic buttons installed in the driver’s cabin,
• GPS systems allowing to trace vehicles in real time.

A virtual corridor of the vehicle’s movement can be also set as an additional precaution. This solution generates an alert informing the forwarder on any unauthorised departure of the vehicle from its designated route.

The basic equipment of vehicles, necessary for pharmaceutical transport, are devices measuring and controlling transport temperature:

• temperature sensor installed in the cargo space, registering transport temperature,
• printers generating transport temperature printouts and control printouts during the shipment,
• GPS systems allowing to control temperature in real time, generate temperature printouts from the level of the forwarder’s computer, and setting alerts of uncontrolled temperature drop/rise.

2. Why is it effective to transport meds by road transport?

When the goods are manufactured, the distributor faces the task of transporting pharma products to warehouses and pharmacies. There are many modes of transport (road, air, sea transport) and all of them have their own strengths and weaknesses.

Why is road transport a good choice?

• Pharmaceutical products must not be transported in one cargo space with other goods, in order to prevent any negative impacts that other goods might have on the quality of the transported products (contamination, release of odours). The cargo space intended for transporting meds must be clean, dry, devoid of any foreign odours. These requirements make road transport the best option, as it is capable of satisfying them in 100%. A dedicated refrigerated truck guarantees that all sanitary requirements will be met.
• Another advantage of road transport is full control over transport temperature. Telematic devices guarantee temperature control and monitoring 24h/7.
• Road transport is also certified transport – the carrier must have the GDP certificate, confirming that all guidelines of the Good Distribution Practice have been satisfied. More information can be found in the 5 arguments in favour of road transport of meds.

3. Why is it worth cooperating directly with the carrier during transport of pharma products?

It is worth considering certified companies when choosing your carrier. What advantages can it get you?

• such a carrier has the GDP certificate, which obliges it to implement and follow the guidelines of the Good Distribution Practice – thanks to that we know that our cargo will be entrusted to a company aware of the strictest quality requirements that must be satisfied during order completion,
• the GDP certificate means a guarantee that the staff involved in the transport is trained and aware of the need to satisfy the terms and conditions of the order,
• more and more often Service Level Agreements are concluded between the customer and the carrier prior to commencing cooperation, which guarantees that the carrier will satisfy all the requirements and guidelines set forth therein.

What are other advantages of direct cooperation with a good carrier?

One of the most important criteria is the fact that cooperation with a qualified carrier minimises the risk of intermediaries. This is guaranteed in relevant agreements signed in the qualification process.

4. What does the carrier qualification process look like?

Ordering transport of meds, you naturally expect a top-quality service. The carrier qualification process is a good practice in this respect. What does it consist in?

• The client defines a number of guidelines to be satisfied by the carrier and expects the carrier confirms them
• Audits are frequently carried out, during which the carrier’s procedures are verified
• If the carrier satisfies the client’s criteria, relevant agreements are concluded, defining specific requirements that need to be satisfied by pharmaceutical transport.

Such a process is worthwhile, because a qualified carrier stands for a guarantee of satisfying the strictest requirements and for safety of an informed and professional partner taking care of your cargo.

5. Documentation in transport of meds

Each pharmaceutical transport order must have an appropriate POD (Proof of Delivery). The basic documents confirming the completion of the pharmaceutical transport service are as follows:

• CMR – the foundation of a completed transport order is the international consignment note, duly signed and stamped by the consignee. This is a document where the driver will find full information on the quantity of goods to be loaded and the required transport temperature. Additionally, all necessary details are entered in this document in the event of any damage / non-conformities.
• temperature printout - there are two options of sending printouts of transport temperature to the client: a printout generated by the driver upon unloading (printout from the on-board printer), or a digital printout generated from the GPS system.

It is a good practice of the carrier to send documents straight after unloading. It is helpful to clarify any non-conformities right when they are detected.

6. Why is it worth entrusting transport of meds to an experienced carrier?

International transport entails an obligation to hold relevant documents and experience. Transport to countries outside the European Union is associated with the need to undergo customs procedures. And not everybody has relevant experience. Time is of essence when transporting pharmaceuticals. A carrier which has been covering such routes for years can guarantee that the customs procedure will be short thanks to the knowledge what to do with the right documents at the right time. It is particularly important in case of express shipments, which shorten the time carriers have at their disposal to the bare minimum.

Additional assets offered by an experienced carrier are as follows:

• knowledge how to deal with crisis situations
• knowledge of legal requirements and regulations
• knowledge of customs procedures

An experienced carrier is a guarantee your cargo is in good hands and will reach the unloading site safely.

7. Handling crisis situations

Like in any other business, pharmaceutical transport is not free from crisis situations. They are sometimes difficult to predict; nevertheless, the carrier should be definitely prepared for them. What are examples of crisis situations?

• Vehicle breakdown
• Failure of temperature measuring equipment
• Theft of the cargo
• Road accident
• Deviation from the set transport temperature

Each crisis situation should have relevant procedures developed, specifying exactly who should do what. Additionally, it is worth training the staff involved in pharmaceutical transport and raising their awareness of the fact that such situations might occur. Developing a risk analysis, considering in detail all risks that might be encountered during transport, will be an added value.

Summary

Transport of pharmaceutical products entails a number of requirements and guidelines. This is caused by unique properties of meds. Participants in the supply chain must be aware of the risk associated with the failure to satisfy the required transport conditions.

We are a transport company boasting a wealth of experience and knowledge, confirmed with the Good Distribution Practice certificate. When choosing the certifying body, we aimed high – we selected an institution of an international reputation, i.e. SGS Polska. We wish to assure our clients that we satisfy the requirements set forth in GDP to the highest standards. Furthermore, we have implemented the ISO 9001:2915 system, which allows us to improve our quality performance even more.

Road transport entails many risks in itself, and transporting pharmaceutical products increases them still. Therefore, we operate based on processes and procedures which allow us to minimise any damage. We operate strictly according to procedures resulting from GDP, and on top of that we adapt our procedures to our clients’ requirements. The company is regularly subjected to external and internal audits, confirming the conformity of our business with relevant procedures.

The specificity of sensitive products makes our clients expect not only safety of transport, but also a guarantee that individuals involved in each stage know all relevant procedures and requirements. Our workers attend introductory and refresher trainings at least once a year. Furthermore, our drivers are equipped with manuals on how to behave during transport.

Manufacturers of pharmaceuticals are particularly sensitive to securing controlled temperature when transporting meds. Eltrans regularly carries out calibration of temperature sensors, securing appropriate temperature during transport, and mapping, which guarantees maintaining optimal transport temperature in extreme temperature conditions. We know how important it is to provide safe and reliable fleet; therefore, every year we invest in new vehicles and innovative solutions. This reduces the risk of technical issues, which might have a negative effect on our services.

If you are looking for an informed partner, which operates according to relevant procedures, knows how to handle demanding goods such as meds – Eltrans satisfies all requirements of the Good Distribution Practice. We approach each client individually during transport, which allows us to satisfy individual requirements of wholesalers. Our personnel involved in the entire process, from qualification to execution, includes trained professionals, who will be happy to answer all your questions at each stage and who will quickly respond to problems or non-conformities. E-mail or phone us, and we will provide you with our customised offer.