Transport of meds in controlled temperature – what are the GDP requirements for transport?

When deciding to become a provider of pharmaceutical transport services, it is necessary to be aware how demanding these goods are. Their specific properties require special commitment of participants in the supply chain because transport temperature must be maintained and goods must be secure at each stage of the distribution process.

GDP certificate – why is it helpful and why is it important?

The Good Distribution Practice Guidelines are a guiding light in pharmaceutical transport. Adherence to them helps to maintain appropriate quality and integrity of pharmaceuticals in the entire supply chain. Carriers wishing to transport meds must undergo a certification process in order to obtain the GDP certificate. It is extremely important, because product integrity must be maintained throughout the entire transport process and precautions must be undertaken in order to make sure that no falsified medicinal product enters the supply chain. The GDP certificate constitutes a confirmation of just that.

Transport of meds vs. quality management

It is a good practice of companies involved in distribution of meds to have a quality management system implemented. It makes it easier to develop the company’s own internal processes. Transport in controlled temperature entails a number of risks that may occur during the process. The quality management system is helpful in defining the risk management rules.

What else should be covered by the quality management system?

• Organisational structure,
• Procedures,
• Processes and resources,
• Measures securing maintaining top quality services and integrity in the supply chain.

A good system is a system which operates throughout the year, which means it is regularly reviewed and improved. The tools used to this end are certainly internal audits and management reviews. During such meetings and inspections we can see how our system operates every day and whether it requires improvements or changes. If we decide to introduce a change that might affect our internal systems, we should control such a change and consider its benefits for our company. The management review is an annual meeting of people involved in the system, aimed to review the year in terms of reaching the goals planned for that year. It is a good moment for a review of complaints and non-conformities. Such a meeting should result in defining subsequent quality-related goals for the coming year.

Transport of meds entails a list of requirements that need to be satisfied. Not every single requirement can be satisfied by the carrier – then it is necessary to use external suppliers. A good example of such contractors are e.g. car washes, garages conducting technical inspections of vehicles, external training organisations. It is a good practice to assess external contractors according to clearly defined criteria, which is very helpful in the process of their qualifications, because periodical appraisals show us what the cooperation looks like and what can be improved.

Transport of meds compliant with the GDP requirements vs. the human factor

The human factor in transport of meds is the foundation of a service well provided. It is our employees who make sure that appropriate transport conditions are maintained all the time. A certified company should have a Responsible Person appointed, whose task is to help to demonstrate that all the GDP requirements are met at each stage of the transport process. It will be an asset if such a person has relevant qualifications and training in the Good Distribution Practice.

As far as trainings are concerned, each employee involved in distribution of meds should be properly trained. A good practice used in companies are introductory trainings, during which employees obtain extensive knowledge relating to transporting pharmaceutical products, and refresher trainings, aimed to brush up on their knowledge during the year. Trainings should be documented so as to be able to confirm attendance and effectiveness .

Theoretical instruction provided to employees is one element of the system. The other is making them aware of their duties and rules of mutual substitution. It is crucial for every employee to be aware of their tasks in the process of distributing meds.

Training and raising the awareness of employees eliminates errors and minimises risks resulting from insufficient knowledge and awareness of necessary actions to be taken in crisis situations.

Good Distribution Practice vs. documentation

The goal of the documentation is to eliminate errors associated with oral transmission of information between participants of the transport process.

The documentation consists of the following elements:

• Procedures
• Instructions
• Contracts
• Registers

If we draw up a new document or edit an existing one, each of these situations requires a confirmation by means of dating and signing. This aims to keep all versions in order and allows to verify what has been amended. Good documentation is legible, understandable, and structured.

Transport of meds compliant with GDP in practice

In transport of meds quality is key. In 2019 we implemented the quality management system according to ISO 9001:2015 and the Good Distribution Practice certification and have been operating according to their principles since then.

We know the requirements of these standards, our employees are properly trained and hold relevant qualifications. New employees take part in introductory trainings first and refresher trainings during the year. We delegate our employees to external trainings organised by reputable training organisations, such as TUV Sud or SGS Polska, to extend their knowledge even more.

We are aware of the importance of proper registration of and dealing with all complaints, returns, suspicions of falsifying pharmaceutical products in the process of transporting pharmaceuticals. We have appropriate procedures in place for such situations. Each non-conformity is considered individually, we develop CAPA plans, and we train our personnel how to deal with crisis situations.

We are aware we are responsible for protecting the goods against damage, falsification, and theft. We apply a number of tools guaranteeing the appropriate temperature and safety of the goods is maintained:

• state-of-the-art telematic systems allowing to monitor temperature conditions online and to trace shipments constitute the foundation of safe transport. The GPS system allows us to set temperature alerts, as well as unauthorised door opened alert,            
• locks – we guarantee double protection of our cold rooms. We secure the doors of the semi-trailer not only with mechanical (SBS) locks, but also with more advanced electronic locks satisfying the requirements of TAPA TSR level 1.

Our vehicles are fully adapted to the requirements set forth in the Good Distribution Practice guidelines:

• we calibrate temperature sensors every year, each refrigerated truck has calibration certificates,
• we secure appropriate distribution of temperature in the cargo space – we systematically map temperature distribution in extreme temperature conditions – our refrigerated trucks have winter and summer mappings.
• we guarantee appropriate thermal insulation conditions – each refrigerated truck has the ATP certificate
• we minimise the risk of technical defects – every year our vehicles are subjected to full technical inspections, and our employees check all the equipment and technical conditions of our vehicles prior to each departure
• we offer the highest sanitary standards – each of our refrigerated trucks has its own cleaning and disinfection logbook.

Pharmaceutical products require detailed control in terms of temperature conditions as well as transport safety at each stage of the distribution process. Our operations department makes sure all shipments reach their destinations on time, satisfying all the relevant requirements at the same time. Contact with our forwarding agents and the quality department is presented in detail already at the very beginning of the qualification process. Consequently, our clients know who to turn to with a given question. Our replies are prompt, because we know that time plays a crucial role in transport. If you want to be certain that your goods will be delivered safely and that you will be provided with suitable support and answers to your questions at each stage of the transport process, contact us, we will deliver your meds on time, maintaining the highest quality standards.