The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Such testing enables the manufacturer to establish or modify recommended storage conditions, retest periods and shelf life or dating period.

Shelf Life Testing

Shelf life testing is important for products subject to degradation over time. In addition to the factors mentioned above, the length of shelf life, especially for long-term implantable devices, may depend on the specific bodily fluids with which the device may come into contact. Shelf life should be adequately supported and substantiated by real-time testing.

Regulatory Requirements

The manufacturers may not be familiar with the regulatory requirements for one part of a combination product due to differences in approval process under different laws and regulations. Specifically, adequate stability testing of drug/device combinations to satisfy these requirements can be a difficult task.

Delay of Product Approval

Without adequate stability testing, the integrity of drug/device combinations may not hold up during manufacturing, storage and transport or during use, resulting in further delay of product approval. It is important to conduct stability studies properly to assure the stability of these combinations, starting from the early stages of drug testing and up to the post-marketing studies to assure its performance.