Medicine transportation: the GDP guidelines
Medicine transportation requires specific handling. It is important that you ship medicines conditioned from a to b. This is because the function of the medicines is compromised when they are improperly stored and transported.
To ensure quality, Good Distribution Practices (GDP) guidelines have been established for wholesalers and manufacturers of human medicines in the Netherlands. The temperature of the shipment is very important here. In this article you will read how to comply with the GDP guidelines.
What are the Good Distribution Practices?
Good Distribution Practice (GDP) is the part of quality assurance that ensures the quality of medicines is maintained through all stages of the supply chain. Increasingly complex drugs are being developed that are even more sensitive to temperature changes, making drug transportation requirements increasingly stringent.
Thus, two of the most important topics of the GDP standards are temperature conditions;
“If cooling elements are used in insulated boxes, they should be placed so that the product does not come into direct contact with the cooling element. Staff should be trained on the procedures for assembling the insulated boxes (seasonal composition) and on the reuse of cooling elements.” (March 7, 2013 Guidelines on Good Distribution Practices for Medicinal Products for Human Use)
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“For temperature-sensitive products, appropriate equipment (e.g. thermal packaging and containers or temperature-controlled vehicles) should be used to ensure that correct transport conditions are maintained between the manufacturer, wholesaler and customer.” (March 7, 2013 Guidelines on Good Distribution Practices for Pharmaceuticals for Human Use) and temperature monitoring;
“Based on mapping, temperature control equipment should be placed to ensure that the control equipment is located where the greatest fluctuations occur.” (March 7, 2013 Guidelines on Good Distribution Practices for Medicinal Products for Human Use)
Who do the GDP guidelines apply to?
The GDP guidelines are designed for wholesalers and manufacturers of human medicines. The Health Care Inspectorate inspects for compliance with the GDP and issues certificates if the site meets these requirements.However, it is important for everyone in the chain, not just the pharmaceutical companies, to ensure the quality of medicines. For example, hospital pharmacists and community pharmacists have established their own professional standards. These include requirements for the storage and transport of medications.
Solutions for GDP medicine transportation
Do you want to transport medicines GDP yourself? By applying our special products, we can create a customized solution for every transport challenge within medicine transport. For example, Coolpack has developed a special insulation envelope, so that the medicines can never come into contact with the cooling element during transport. We also offer special size EPS boxes, so that even the smallest shipment can be conditioned.
In addition, we have noticed an increasing demand for Phase Change Materials (PCM) to keep drugs at the right temperature. The PCM cooling elements freeze or melt near the drug’s protection temperature, leading to more effective and enhanced protection. The range for the PCMs is between -21°C and +21°C. The temperatures are achieved through salts, glycols and kerosene. In consultation, we can determine the appropriate temperature and gel.
For medicine transport, sponge packs are mainly chosen . It is specially available with bubble wrap on the top to protect fragile medicines. It can also be filled with PCM for extra protection. They are designed for reliable protection to keep your medicines at the right temperature during transport. The sponge pack is vacuum packed. As a result, it has a consistent weight and therefore will never change shape during freezing and thawing.
Drug transport for wholesalers
To ensure quality in shipments of medications to hospitals and pharmacies, we offer both gel packs and EPS boxes. We can even offer a safety stock of gel packs. Moreover, if distance permits, it is possible to deliver the gel packs already frozen in combination with a coldstore. In situations like this, we also recommend using crates instead of boxes in which the gel packs will be packed. This is more efficient (faster freezing time) and more economical (no boxes component in the price).
Drug transport for pharmacies
This particularly concerns the last piece of the distribution chain: drug transport from pharmacy to patient. Here, medicines are often not yet shipped correctly. We offer special products for this, such as small gel packs, smaller EPS boxes, absorption mats and insulation envelopes. In addition, we also have NFC temperature loggers. This allows temperature monitoring. We also offer security and warning labels.
Opinion
Want to know which refrigerated solution best suits your situation? Then contact Coolpack directly for personal advice. One of our experts is always ready to prepare a customized solution for you.
Read the entire March 7, 2013 Guidelines on Good Distribution Practices for Medicinal Products for Human Use here
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