What are the specific requirements for pharmaceutical transport?
The quality of medicines and the safety of their transport are key issues. To achieve this, those involved in transporting pharmaceutical products rely on Good Distribution Practices (GDP) for wholesale distribution of pharmaceutical products. This document guarantees the safe supply of healthcare products from the supplier to the final recipient. GMP covers a wide range of issues, including traceability, temperature control and risk management.
Best practices for transporting pharmaceutical products
The official text of the BPD was completely reworked in 2013. This new version replaces the 1994 version, and devotes an entire chapter to pharmaceutical transport. Good practices favor dedicated transport, carried out by professionals trained in the handling and routing of healthcare products. The guide reinforces the role and responsibilities of a "responsible person" in charge of ensuring compliance with good practices.
Nationally and internationally regulated distribution
BPDs govern the distribution and transport of medicines at European and national level. These standards guarantee the quality and safety of medical products. The pharmaceutical supply chain involves many players, from the manufacturer to the end customer. Each stage is subject to documented quality controls.
In France, each pharmaceutical company appoints a responsible pharmacist. When it comes to transport, this manager must call on a company specializing in pharmaceutical logistics. He/she ensures that the carrier uses suitable vehicles and that the personnel are trained in this type of transport. For its part, the carrier is required to comply with all the recommendations indicated by the manufacturer and printed on the packaging.
Goods transport subject to temperature control
Temperature control is a major issue in pharmaceutical logistics. A growing number of medicines are considered to be heat-sensitive. It is imperative that the means used to transport this particular merchandise maintain temperature ranges throughout the mission. Excessive temperature variations have a direct impact on the active ingredients contained in certain products , and therefore on their efficacy.
Refrigerated vehicles must be equipped with monitoring devices. These devices regularly monitor temperature, humidity and pressure. Failing this, the freight is always accompanied by independent means of recording these data. All this equipment is checked and calibrated several times a year.
Specialized teams for the road transport of medical products
Pharmaceutical transport can only be entrusted to a specialized company. The company's staff and drivers are trained in good distribution practices for healthcare products. They know how to handle fragile and heat-sensitive packages. They master the use of refrigerated vehicles and isothermal devices. These logisticians are also able to react quickly in the event of an incident or break in the cold chain.
This type of merchandise can only be delivered to premises authorized to receive it. Packages are delivered directly to the designated recipient. In the case of express deliveries outside working hours, the recipient must designate in writing the persons responsible for receiving the packages.
Risk management in the transport and distribution of medicines
Risk management is an integral part of any road transport assignment. Upstream, the distributor and the transport company draw up specifications. This document focuses on delivery routes, load breaks and temperature control points. The carrier must report any incidents or temperature deviations occurring during transport to the supplier and consignee.
From supplier to end customer: pharmaceutical product traceability
The safety of the drug chain is ensured upstream by Good Manufacturing Practices (GMP). This system of processes and documents was set up by theWorld Health Organization. It guarantees the conformity of healthcare products at every stage of their manufacture. GMP is complemented by BPD, which devotes several sections to temperature traceability.
A new system to secure every link in the supply chain
Pharmaceutical traceability is a fundamental need. It helps combat drug trafficking and falsification. This tracking is based on a new coding system introduced in 2009. A Datamatrix code has replaced the standard barcode. It contains the usual information (batch number, expiration date, etc.) and a 13-digit presentation identification code (CIP). This unique serial number is registered in a national and European directory.
Solutions to improve temperature traceability for heat-sensitive products
Traceability of pharmaceutical products is an important aspect of transport risk management. According to the BPD, the logistics service provider must prove at all times that the quality and integrity of medicines have not been compromised. Traceability does not rely solely on the use of a refrigerated or isothermal container. BPD recommends the use of temperature monitoring solutions. Thanks to real-time monitoring, drivers are immediately alerted in the event of any anomaly or overshoot.
Pharmaceutical transport: the need to master the cold chain
Respecting the cold chain guarantees the integrity of heat-sensitive products. The means and conditions of transport must prevent load breaks and ensure that products are well preserved from loading to delivery. There are three temperature ranges: below -20°C, between +2 and +8°C, and between +15°C and +25°C.
Pharmaceutical transport at ambient or regulated temperature
The +15°C/+25°C temperature range appears to be the easiest to manage. It does not require refrigerated vehicles or special equipment. However, the medicines concerned cannot tolerate temperature variations. Summer and winter alike, the temperature must remain stable and constant. A simple isothermal crate is often not enough. In such cases, cold logistics specialists use various passive devices, such as eutectic plates or thermopallets.
Temperature-controlled transport of medical products
The transport of healthcare products is subject to ATP regulations (Agreement on the Transport of Perishable Foodstuffs). This international agreement covers vehicles, temperature limits and hygiene and safety standards.
The carrier is responsible for temperature-controlled transport. As he is subject to an obligation of result, he must choose the categories and classes of equipment that will enable him to maintain the recommended temperature throughout the duration of the transport.
The publication of BPD in 2014 strengthened temperature control requirements. This led to the creation of the Certicold Pharma label. It is awarded to equipment manufacturers and transporters who meet particularly demanding specifications.
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