Many pharmaceutical products are sensitive biological substances that progressively lose their potency. The loss of potency is much faster when the product is exposed to temperatures outside the recommended range. All losses of potency are permanent, irreversible and cumulative. This means that if a temperature sensitive product is exposed several times it may lose its potency completely due to cumulative damage. It is necessary to have a cold-chain system in place to ensure that products are stored and transported in a validated and verifiable way to retain the integrity of the product up to time of administration.
The TCP Logistics cold chain system comprises of three main elements:
- Personnel – who use and maintain the equipment
- Equipment – for safe storage and transportation of the product
- Procedures – to manage the process and control distribution