GDP and ISO9001:2015 certificate in pharmaceutical transport

In April, we passed another supervision audit by the SGS Polska certification body, thanks to which we are entitled to transport medicines for another year.

What gives GDP certification

When carrying out the transport of drugs, it should always be taken into account that the safety of pharmaceuticals is fundamental. This type of transport entails the need to pay special attention to the conditions of transport and to ensure protection against theft and interference in the transport of medicinal products by third parties.

The GDP requirements are intended to ensure safe transport of drugs, without the risk associated with, among others, with contamination, mechanical damage or theft.

 

Why are GDP and ISO9001:2015 certificates important in the transport of medicines?

The transport of pharmaceuticals requires strict adherence to GDP (Good Distribution Practice) guidelines, which cover all aspects of the transport process, including: temperature control, preventing mechanical damage, preventing the introduction of counterfeit drugs into the supply chain. They define all the requirements that must be met by the equipment used to transport medicines. The GDP certificate is a document that ensures that the company complies with these regulations and can safely transport medicines.

The ISO9001:2015 certificate is an added value for a carrier that deals with the transport of medicinal products. It ensures that pharmaceuticals will be handled with the utmost care and precision during transport. It helps to maintain quality standards and reduce the risk associated with the transport of sensitive goods.

 

How to maintain the Good Distribution Practice certificate?

The transport of pharmaceuticals is related to the relevant provisions of law - the carrier must comply with the principles of pharmaceutical law, and the transport process must comply with Good Distribution Practice.

Since 2019, we have been a certified drug carrier. What does it mean? The wholesale transport of medicinal products imposes specific requirements on the carrier, which are first verified during the certification audit, and in subsequent years, supervision audits are carried out by the certification body. Since 2019, we have successfully passed a certification audit, supervision audits and re-certification. Maintaining the certificate means continuous work and improvement of internal procedures and the quality management system.

Pharma transport and GDP Guidelines

The transport company involved in the transport of pharmaceuticals must ensure the safety of pharmaceuticals and carry out the transport of drugs at the required transport temperature. Guidelines in accordance with Good Distribution Practice, which impose specific requirements on the carrier, are helpful in the implementation of the transport process. The individual chapters help you with how to:

- transport medicines,

- protect them from the harmful effects of possible external conditions,

- protect against mechanical damage,

- ensure that medicines arrive safely from the point of origin to the point of collection.

An important part of the guidelines is the chapter on falsified medicines. The carrier must be aware of ensuring safety at every stage of transport, so that from the point of origin to the point of receipt the drugs are protected against the possibility of introduction of counterfeit medicinal products. An important issue is the development of a procedure thanks to which the carrier will be able to qualify customers. This practice minimizes the risk of loading products from unauthorized entities.

Meeting the GDP guidelines is a guarantee that pharmaceuticals are transported in accordance with the law, the conditions for the transport of drugs are maintained - air humidity and temperature at the appropriate level. The Good Distribution Practice certificate is a guarantee that only an aware, competent and trained carrier deals with the transport of medicinal products.

Summary

Medicinal products are a specific type of commodity. Medicines must be stored at the appropriate temperature from the moment of production and their sender to the final place of delivery. Failure to comply with the appropriate conditions for the transport of pharmaceuticals is a risk related to the loss of health of the final recipient of the goods, i.e. the patient. It is impossible to make the transport temperature too low or too high temperature of the transport. Any change in the required transport temperature means irreversible changes in the product, which may result in exposure of the recipient of the drug. The temperature can be controlled using friendly telematics systems, which are already a standard. An example is electronic temperature monitoring using GPS. Thanks to this solution, we are sure to maintain the right temperature in the cargo space. The systems have the ability to send alarms that inform about an unauthorized increase or decrease in the transport temperature. An additional option is to ensure the safety of transport by generating an alarm for unauthorized opening of the refrigerator door.

The transport of drugs imposes a number of requirements on the carrier that must be met. It should be ensured that the transport takes place in appropriate conditions. It is important that aware and trained employees take part in the transport of pharmaceuticals, and that only fully adapted rolling stock is used for transport, which will ensure transport in the required conditions and temperature.

As a certified carrier, we meet all the guidelines of Good Distribution Practice. Our staff is a trained, qualified and aware team. If you have questions about how we meet the requirements in pharmaceutical transport? Call or write: jakub@eltrans-tsl.pl, +48 519 756 785.

 

 

Author of the text: Małgorzata Łazowska