Pharmaceutical companies and manufacturers have the responsibility of delivering quality medicinal products with correct attributes to patients. All medical products are affected by temperature variations and may lose potency or even cause harm.
What is Temperature Excursion?
Temperature excursion happens when medicines and medical products are stored at a temperature that is outside of the specified temperature range as defined on its label. The excursion has a significant impact on the quality, efficacy, and safety of the products. This can result in a significant impact on the safety of the patient if it goes undetected or not effectively communicated creating delays in dosing the patients.
Reasons for Temperature Excursion
Medicines and products are transported all over the world exposing them to temperature variations. Medicinal products are often stored before final use.
The transport and storage of medicinal products need to be monitored. Many times uncontrolled situations of temperature deviation may happen. In such conditions, the storage of medicines might experience temperature deviations from the specified values.
Temperature excursion can happen in transportation or storage. Temperature excursions in transport are common. The processes of transportation and places of transport are less reliable of pharmaceutical processes.
Common reasons for a temperature excursion
At such times temperature, sensitive products may experience temperature excursion outside the specified range. These events cannot be predicted and are therefore, challenging.
Areas of Temperature Excursions
There are two areas of temperature sensitivity, and products show different behaviors in these conditions.
Sensitivity to High Temperatures
Medicinal products that are sensitive to high temperatures may deteriorate in the following ways.
Sensitivity to Low Temperatures
Medicinal products that are sensitive at low temperatures often exhibit-
Many medicinal products are sensitive to both absolute temperature and temperature change, for example, some creams lose properties after freeze-thaw or temperature cycles.
Action steps after temperature Excursion
If a temperature excursion happens, some crucial steps are needed immediately. Thses are-
Manufacturers are required to understand their responsibility and accountability for any product’s quality until its final use. They have to guarantee the safety, efficacy, and quality of their medicinal product stated in the registration files will remain stable until final use. In case of temperature excursions, the manufacturer needs to take adequate steps.
Temperature excursions are challenging to handle because it is often impossible to predict the next condition the product might be exposed to. There could be natural disasters or human-related events like accidents that can hamper transportation.
Temperature excursion management is crucial as resupplying the material is expensive and the storage space at clinical sites can be a serious concern. The success of clinical trial and research depends on to maintaining the quality of medicines and medical products. Therefore manufacturers should be vigilant about providing the best.
However, with proper control and monitoring the risk of a temperature excursion can be minimized. An efficient supply-chain management can reduce the chances the temperature excursions.