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Critical Importance of Comparator Temperature Excursion for a Clinical Trial!

Posted by Doctor Dan on May 4, 2017 11:46:36 AM

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.

CR -Chemist working on the lab 790 .jpg

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

  • Change in forecasted transport route
  • Change in scheduled travel plans
  • Less than adequate storage facilities

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.

  • Temperature above the range
  • Temperatures below the range

Sensitivity to High Temperatures

Medicinal products that are sensitive to high temperatures may deteriorate in the following ways.

  • Decrease active ingredient content through transformation of degraded components
  • Depreciation of formulation properties (coloration of some components, dissolution rate modification, or separation of emulsions)

Sensitivity to Low Temperatures

Medicinal products that are sensitive at low temperatures often exhibit-

  • Loss therapeutic properties
  • Irreversible changes in active ingredient structures of the product

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-

  • Segregate the affected material
  • Stop dispensing the affected material
  • These segregated material should be still stored according to the instructions on the product label.
  • Rescheduling patient visits until the final decision on fitness of use of affected material by the pharmaceutical company

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.

Topics: Clinical Research