Good Distribution Practice (GDP) refers to the sum of measures that ensure the quality and integrity of medicinal products is maintained by controlling the distribution and supply chain.
The production, transport and storage of medicinal products is centred on one issue:
The safety of patients, for whom these medicines are sometimes vital.
The transport of pharmaceutical products in accordance with GDP guidelines is of crucial importance in order to ensure the integrity and quality of medicines during transport.
Furthermore, the documentation and qualification of employees are decisive features of pharmaceutical transport in accordance with GDP.
The benefits include the safety and quality of medicines, compliance with regulations and the trust of customers and patients.
One of the most important features of pharmaceutical transport in accordance with GDP is strict temperature control. Pharmaceutical products are often very sensitive to temperature fluctuations, so the means of transport and containers must be able to maintain and monitor the required temperatures. This requires the use of specialised refrigerated vehicles with appropriately qualified systems.
Documentation and records
GDP requires comprehensive documentation and recording during transport. This includes information on temperature monitoring, product identification, the transport route and the parties involved. The documentation serves to ensure the traceability of the medicines and compliance with the standards.
GDP transport requires qualified personnel who have the necessary expertise for the requirements and risks of pharmaceutical transport. Employees acquire the necessary qualifications through training and courses that are specifically geared towards the handling of pharmaceutical products in logistics.
Safety and quality of pharmaceuticals
The GDP requirements ensure that pharmaceutical products are transported in accordance with the necessary quality and safety standards. This ensures that the effectiveness of the medicines is maximised when they are administered to patients.
Compliance with regulations
Compliance with GDP guidelines is often required by law and helps to ensure that companies fulfil regulatory requirements.
Customer and patient confidence
Pharmaceutical companies are obliged to have their products transported and stored in compliance with GDP. This also strengthens the confidence of their customers and patients in the effectiveness of the treatment. The certainty that the products are delivered safely and in perfect condition is crucial for the success of a therapy.
TAPA TSR (Transported Asset Protection Association - Trucking Security Requirements) is an internationally recognised standard for high-security transport. This standard was developed to minimise the risk of theft during transport.
Compliance with the TAPA TSR standard helps to ensure the safety of drivers and goods during transport and to protect companies from financial losses and image problems.
TAPA has set itself the task of increasing the safety of transport and storage of goods, as well as the safety level of lorry parking areas worldwide, and has drawn up corresponding standards for this purpose.
These are the most important features and benefits of high-security transport in accordance with the TAPA TSR standard:
The TAPA TSR standard contains specific security requirements and specifications for processes, personnel and equipment of means of transport, among other things. These requirements are designed to protect against theft and sabotage and are divided into three security levels (TSR 1= highest security standard, TSR 2= medium, TSR 3= lowest).
Companies that carry out TAPA TSR transports undertake to carry out a comprehensive risk assessment for each transport and to implement appropriate measures against these risks. This enables potential hazards to be recognised and appropriate safety measures to be taken.
Staff involved in high security transport receive specialised training to ensure that they adhere to and implement the required security protocols and procedures.
The vehicles used for these transports are often required to be equipped with specialised security technology, such as GPS tracking, alarms and locking systems.
The TAPA TSR standard requires continuous monitoring of transports by so-called AMICs (Alarm Monitoring and Intervention Centres) to ensure that the route specifications are adhered to, the locking systems of the means of transport are activated and the driver can trigger an alarm at any time in an emergency, to which the AMIC then reacts accordingly.
Companies that are certified in accordance with the TAPA TSR standard undergo a corresponding audit by an independent certification body (e.g. Bureau Veritas).
(e.g. Bureau Veritas, TÜV, DQS).
Reduction of losses
The most important benefit of high-security transport in accordance with the TAPA TSR standard is the significant reduction in theft and sabotage during transport. This helps companies to minimise financial losses.
Protecting the supply chain
High security transport helps to protect the integrity of the supply chain. This is particularly important for companies transporting valuable or sensitive goods, such as electronics, pharmaceuticals or jewellery.
Companies that comply with the TAPA TSR standard can strengthen the trust of their customers. Customers know that their goods are safe during transport, which ensures the availability of goods to the recipient and thus increases customer satisfaction.
Compliance with the TAPA TSR standard can have a positive impact on insurance costs as there is a lower risk of theft.
Transport in accordance with a TAPA TSR standard is agreed between the client and the contractor in accordance with one of the three possible security levels (TSR 1 to TSR 3, see above). The contractor undertakes to carry out the transport in accordance with the agreed standard in compliance with the applicable national laws. If even one of the points is disregarded/neglected, there is a risk of accusations of gross negligence or even wilful intent in the event of damage, as well as the withdrawal of certification by TAPA.
TAPA cooperates with security authorities (police, customs, Interpol, FBI) and now also provides advisors to various EU committees (e.g. for the creation of guidelines for safe lorry parking areas). TAPA's standards generally apply globally, but naturally follow the respective legislation of the countries in which it is active. This means that TAPA's experts and member companies are always up to date with the latest developments in the field of theft-related crime and the measures that can be taken to combat it.