Cold Chain Management For Sensitive Goods
Pharma Bio World|February 2019
Cold Chain Management For Sensitive Goods

Packaging, route planning and risk analysis ensure safe conditions during transportation of delicate drugs. Drugs are sensitive goods to transport, which can be subject to irreversible damage if they are stored or transported at temperatures outside the tolerated range. If the temperature falls below or rises above the specified range the quality of drugs requiring refrigeration can be seriously affected and they may cease to be effective. This article therefore describes how transport conditions during the transportation of drugs can be optimised through suitable packaging, individualised process design, the analysis and assessment of potential risks and close collaboration between the sender and the freight carrier.

Nowadays drugs are transported over long distances both over land and by air. In addition to choosing the right packaging and correct cooling system, the transport process must ensure that the drugs reach the patient without having suffered any loss of quality as a result of the negative effects of inappropriate temperatures.

During transportation drugs are subject to the same provisions with regard to maintaining a specified temperature range as applicable during storage. Drugs requiring refrigeration – medication which must be stored at temperatures between 2 °C and 8 °C - can either be transported using a controlled active cooling system or an uncontrolled passive cooling system. By active cooling system we mean the use of refrigeration units in appropriately equipped vehicles or active air freight cargo containers. Passive cooling systems involve the use of insulated cool boxes in which cool packs are packed along with the goods to be transported in order to cool them.

Requirements in respect of the transportation of drugs

Legislation requires proof that medical products incur no damage as a result of storage or transportation1. In Annexure 5 of Guideline 937 under the heading ‘Good Distribution Practices for Pharmaceutical Products’ (GDP), the WHO stipulates the storage conditions to be complied during transportation and the permitted deviations2. The US Pharmacopeia (USP) also demands temperature control and monitoring during transportation3. In the EU, the 1994 ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ apply. These guidelines likewise require that for drugs which need to be stored at a specific temperature, suitable conditions are to be maintained during transport4. However, since there have been considerable changes in transport and logistics since 1994, the European Commission has issued new draft guidelines (EU Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use). These new guidelines take into account the general advances in the practices employed in storage and transportation, as well as the ‘Directive 2011/62/EU’ on combatting counterfeit drugs, and will replace the 1994 guidelines in the coming months.

The above brief summary of the legal requirements shows that there are differences between the conditions for the storage and transportation of drugs set out in the GDP (Good Distribution Practice) guidelines issued by the authorities in different countries. These include quality assurance requirements which must be taken into account by both the pharmaceutical companies and their logistics partners during the storage and transportation of drugs. The fact that the GDP guidelines are not harmonized globally adds to the complexity of transporting drugs. For example, American legislation requires temperature monitoring, which is not required in the existing EU guidelines. Exceeding or falling below the specified temperature range for a particular product during transportation can have a decisive effect on the quality of the drug, even if these limits are exceeded only briefly.

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February 2019