Stability Testing for the Pharmaceutical Industry

Any company which manufacturers pharmaceuticals have to send their products through rigorous testing and meet high-level standards. This is especially true for any company selling their product in Europe or North America. The standards are extremely high and the rules very complex, with many different tests that a new pharmaceutical product must undergo. One of these tests is called stability testing.

Important info is given by that stability testing provides data on how a drug component behaves under various environmental conditions. It is intended to simulate the processes of shipping and storing a pharmaceutical product in a retail pharmacy environment. This allows regulatory agencies to determine an appropriate shelf life for the product.

During stability testing, a number of different factors are studied. These include light levels, humidity, and temperature, among others. Generally, a product is only tested to the points which are likely to occur in the normal handling of the product. Handling outside of those ranges will affect the stated shelf life; for example, if a capsule gets very hot during transport, it will not last as long on store shelves.

Most pharmaceutical companies hire an outside agency to do their stability testing. These outside agencies must also meet strict standards. It is important that the testing site be climate-controlled, for example, in order to get clean data from the testing. Constant monitoring of the product is necessary to ensure there is no tampering or negligence.

Stability testing is just one of many tests a pharmaceutical product must undergo. This type of testing ensures that a product is safe and effective once it reaches pharmacy shelves so that consumers can purchase their medications without fear. These tests may be time-consuming and expensive for the company manufacturing the drug, but they are infinitely valuable to the person buying it.