What are GDP guidelines?
Short answer: GDP guidelines (Good Distribution Practice) are the European rules that prescribe how medicines retain their quality during storage and transport. The six pillars: a quality management system, trained personnel, suitable facilities, complete documentation, validated and monitored transport conditions, and procedures for complaints and recalls.
Medicines are often vulnerable products. Temperature fluctuations, moisture, light and mechanical shocks can affect their efficacy. GDP guidelines prescribe precisely how these products can be transported and stored safely and effectively, from manufacturer to patient.
The key pillars of GDP
- Quality management system: every company in the distribution chain must have a quality system
- Personnel: employees must be trained in GDP procedures
- Facilities and equipment: storage and transport must be suitable for the product
- Documentation: all steps must be recorded in a verifiable way
- Shipping activities: temperature monitoring and validation of transport conditions
- Complaints and recalls: clear procedures in the event of problems
Temperature monitoring under GDP
An important part of GDP is continuous temperature monitoring during transport. With a data logger, you can record the temperature throughout the entire transport. In the event of any deviations, you can then demonstrate what happened.
What does GDP mean for your packaging?
For GDP-compliant transport, the right packaging is important. Cooled Solutions offers various packaging solutions suitable for GDP-compliant transport: from EPS boxes with validated insulation values to pallet covers for large shipments.
Who actually has to comply with GDP?
GDP covers the entire chain from manufacturer to customer. That means several parties have a role: the manufacturer or wholesaler, the carrier and sometimes also the pharmacy or clinic that receives the goods. Which obligation lies with whom depends on your position in the chain and on your licences. If this is not clear for your situation, put the question to your responsible person for quality. A packaging supplier cannot make a statement on that.
What a packaging supplier can do: help you choose the box, cooling elements and logger, and give you information with which you can set up your own validation. Cooled Solutions operates an ISO 9001 certified quality system and supplies packaging that meets GDP and IATA as stated on our site. The final responsibility for the shipment remains with you as the shipper.
Checklist for a chilled pharma shipment
Go through these points before every new route:
- Temperature range: which range is stated on the label or in the product specification of the medicine?
- Duration of the route: calculate the journey time including waiting time at transhipment and customs. Add a margin.
- Season and route: a route in summer calls for something different from the same route in winter.
- Packaging configuration: which box, how many cooling elements and placed in what way?
- Preparation: how long and at what temperature are the cooling elements pre-cooled or conditioned?
- Monitoring: which logger goes along and who reads it out on arrival?
- Deviations: what does the recipient do if the temperature goes outside the range?
Questions you can ask your packaging supplier
- What data can you provide on the insulation of the box, such as wall thickness and capacity?
- How is the production of the box monitored, and is the quality the same from batch to batch?
- Which cooling elements do you recommend for my temperature range, and how should I prepare them?
- Can I test the packaging first with data loggers on my own route?
- What about lead time and stock if I need to reorder quickly?
A good answer is concrete. Be careful with suppliers who give guarantees without knowing which route, which filling and which season you have. The actual performance always depends on the outside temperature, the filling of the box and the cooling elements.
Pitfalls in practice
- Validation from memory: a configuration that works on paper has not yet been tested on your own route. Run a test shipment yourself with a logger.
- Wrongly prepared cooling elements: starting too cold or too warm gives a different curve from what you expect. Record the procedure and stick to it.
- Box too large: empty space warms up faster. Choose the smallest box in which everything fits neatly.
- Logger without agreement: a logger that nobody reads out does not help. Agree who looks at and stores the data.
- Weekend stop: a shipment that departs on Friday often stands still longer than planned. Allow for that.
Frequently asked questions
Is an EPS box automatically GDP-compliant?
No. A box is one component of a transport process. Whether that process complies depends on the validation, monitoring and documentation that you set up yourself. The box has to match your route and temperature range.
Do I always need a data logger?
For pharma shipments, monitoring is a fixed part of GDP. Whether you log per shipment or by sampling is determined by your own quality system. See our data loggers for the options.
Where can I find packaging for medicines?
Look at cold chain packaging for medicines and also read our explanation of shipping medicines chilled.
Do you need advice on GDP-compliant packaging? Please contact our sales support team via the contact page.
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