Why Is Storage Temperature Important For Medicines?
The temperature at which the medicine is stored and transported is important in maintaining the quality of the medicine.
Medicines stored at incorrect temperature can render it ineffective and may cause a safety concern.
Stability studies are conducted on all medicines which are granted marketing authorization or Product Licence to demonstrate that they are effective at a specific temperature for a certain length of time.
The two most common temperature ranges for medicinal products are:
- cold storage, which is 2°C and 8°C
- below 25°C [although some medicines now state 30°C in reference to EEC regulations].
- The patient could be a risk
- It may be necessary to "recall" which can be expensive
- There could be loss of confidence in the company
- There may be regulatory action, such as revocation of the wholesale dealer's licence
What does good storage and distribution practice involve?
- A quality system which records all procedures
- A continuous effort to integrate improved procedures
- A reliable distribution strategy for ambient and cold storage and distribution
- A risk assessment programme
More information is available in this very informative, essential guide if you are considering starting your own wholesale pharmaceutical business
